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NCT00923013 · ADVERSE EVENTS

Adverse events

Cladribine With Simultaneous or Delayed Rituximab to Treat Hairy Cell Leukemia · Source last updated 2026-08-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All-Cause Mortality was monitored/assessed up to 16 years. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent, up to day 35 for participants receiving cladribine only, up to day 80 for participants receiving cladribine plus rituximab, and up to day 80 for participants receiving delayed rituximab.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab

Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (ramdomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.

4 / 3434 / 342 / 34
Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab

Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (ramdomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.

2 / 3231 / 322 / 32
Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)

Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (ramdomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).

2 / 3434 / 340 / 34
Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)

Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (ramdomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).

5 / 3029 / 301 / 30
Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1)

Participants with Hairy Cell Leukemia (HCL) without prior course of purine analog to be directly assigned to Arm 3 (25 participants; after completion of the 68 participants without prior purine analog in Cohort 1). Cladribine + Rituximab (Rituximab will be administered just before rather than after the 1st of the 5 daily doses of cladribine

4 / 2524 / 250 / 25
Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine

Participants with Hairy Cell Leukemia Variant (HCLv) to be directly assigned to Arm 3 (20 participants). Cladribine + Rituximab (Rituximab will be administered just before rather than after the 1st of the 5 daily doses of cladribine

3 / 2019 / 205 / 20

Group identifiers: EG000: Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab · EG001: Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab · EG002: Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) · EG003: Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) · EG004: Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1) · EG005: Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Cardiac ischemia/infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Creatinine
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Death not associated with CTCAE term::Death NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Death not associated with CTCAE term::Disease progression NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      25
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Dyspnea (shortness of breath)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      25
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Fatigue (asthenia, lethargy, malaise)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      25
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Hypertension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Hypotension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Hypoxia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Bladder (urinary)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Infection

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      34
      num Events
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
      num Events
      4
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      34
      num Events
      10
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      30
      num Events
      5
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      25
      num Events
      4
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      34
      num Events
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
      num Events
      3
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      34
      num Events
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      25
      num Events
      6
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      20
      num Events
      6
    term
    AST, SGOT(serum glutamic oxaloacetic transaminase)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      34
      num Events
      11
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      32
      num Events
      7
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      34
      num Events
      13
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      30
      num Events
      10
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      25
      num Events
      4
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      20
      num Events
      6
    term
    Albumin, serum-low (hypoalbuminemia)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Alkaline phosphatase
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      25
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Allergic reaction/hypersensitivity (including drug fever)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      25
      num Events
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Anorexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      25
      num Events
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Bicarbonate, serum-low
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      34
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      32
      num Events
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      34
      num Events
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      30
      num Events
      7
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      25
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Bilirubin (hyperbilirubinemia)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Bronchospasm, wheezing
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Bruising (in absence of Grade 3 or 4 thrombocytopenia)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      25
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    CD4 count
Complete source fields
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    34
    description
    Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (ramdomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    4
    serious Num At Risk
    34
    title
    Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab
  2. deaths Num Affected
    2
    deaths Num At Risk
    32
    description
    Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (ramdomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.
    id
    EG001
    other Num Affected
    31
    other Num At Risk
    32
    serious Num Affected
    2
    serious Num At Risk
    32
    title
    Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab
  3. deaths Num Affected
    0
    deaths Num At Risk
    34
    description
    Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (ramdomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).
    id
    EG002
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    2
    serious Num At Risk
    34
    title
    Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
  4. deaths Num Affected
    1
    deaths Num At Risk
    30
    description
    Participants with Hairy Cell Leukemia (HCL) with (62 participants) and without (68 participants) prior course of purine analog to be randomized between Arm 1 and Arm 2 (ramdomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).
    id
    EG003
    other Num Affected
    29
    other Num At Risk
    30
    serious Num Affected
    5
    serious Num At Risk
    30
    title
    Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
  5. deaths Num Affected
    0
    deaths Num At Risk
    25
    description
    Participants with Hairy Cell Leukemia (HCL) without prior course of purine analog to be directly assigned to Arm 3 (25 participants; after completion of the 68 participants without prior purine analog in Cohort 1). Cladribine + Rituximab (Rituximab will be administered just before rather than after the 1st of the 5 daily doses of cladribine
    id
    EG004
    other Num Affected
    24
    other Num At Risk
    25
    serious Num Affected
    4
    serious Num At Risk
    25
    title
    Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1)
  6. deaths Num Affected
    5
    deaths Num At Risk
    20
    description
    Participants with Hairy Cell Leukemia Variant (HCLv) to be directly assigned to Arm 3 (20 participants). Cladribine + Rituximab (Rituximab will be administered just before rather than after the 1st of the 5 daily doses of cladribine
    id
    EG005
    other Num Affected
    19
    other Num At Risk
    20
    serious Num Affected
    3
    serious Num At Risk
    20
    title
    Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      34
      num Events
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
      num Events
      4
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      34
      num Events
      10
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      30
      num Events
      5
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      25
      num Events
      4
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      34
      num Events
      13
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
      num Events
      3
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      34
      num Events
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      25
      num Events
      6
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      20
      num Events
      6
    term
    AST, SGOT(serum glutamic oxaloacetic transaminase)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      34
      num Events
      11
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      32
      num Events
      7
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      34
      num Events
      13
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      30
      num Events
      10
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      25
      num Events
      4
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      20
      num Events
      6
    term
    Albumin, serum-low (hypoalbuminemia)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Alkaline phosphatase
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      25
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Allergic reaction/hypersensitivity (including drug fever)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      25
      num Events
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Anorexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      25
      num Events
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Bicarbonate, serum-low
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      34
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      32
      num Events
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      34
      num Events
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      30
      num Events
      7
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      25
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Bilirubin (hyperbilirubinemia)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Bronchospasm, wheezing
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Bruising (in absence of Grade 3 or 4 thrombocytopenia)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      25
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    CD4 count
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Cardiac ischemia/infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Creatinine
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Death not associated with CTCAE term::Death NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Death not associated with CTCAE term::Disease progression NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      25
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Dyspnea (shortness of breath)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      25
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Fatigue (asthenia, lethargy, malaise)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      30
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      25
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Hypertension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Hypotension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      30
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Hypoxia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Bladder (urinary)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      25
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Infection
time Frame
All-Cause Mortality was monitored/assessed up to 16 years. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent, up to day 35 for participants receiving cladribine only, up to day 80 for participants receiving cladribine plus rituximab, and up to day 80 for participants receiving delayed rituximab.

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Preserved source evidence · Not medical advice