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NCT01059786 · ADVERSE EVENTS

Adverse events

Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia · Source last updated 2026-07-22

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
Date treatment consent signed to date off study, approximately 103 months and 19 days; 133 months and 11 days; 111 months and 15 days; 102 months and 25 days; 44 months and 14 days; and 19 months and 2 days for each group respectively.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Non-Randomized to 70 mg/m2 Bendamustine-Rituximab

Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 70 mg/m\^2 for initial tolerability study (closed) Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles 6 participants to bendamustine 70 mg/m\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.

0 / 66 / 60 / 6
Non-randomized to 90 mg/m^2 Bendamustine-Rituximab

Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 for initial tolerability study (closed) Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 6 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated

0 / 66 / 60 / 6
Randomized to 90 mg/m^2 Bendamustine-Rituximab

Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 Rituximab: 28 participants Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine:28 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.

8 / 2828 / 283 / 28
Randomized to Pentostatin-Rituximab

Treatment Assignment Code 2 (TAC 2) Rituximab + Pentostatin Pentostatin: 28 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle. Rituximab: Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.

7 / 2828 / 285 / 28
Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab

Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 or Rituxan + Pentostatin After initial tolerability studies are completed. Non-randomize up to 4 total participants to Bendamustine and/or Pentostatin with Rituximab Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 1-4 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle Pentostatin 1-4 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle. Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.

0 / 11 / 10 / 1

Group identifiers: EG000: Non-Randomized to 70 mg/m2 Bendamustine-Rituximab · EG001: Non-randomized to 90 mg/m^2 Bendamustine-Rituximab · EG002: Randomized to 90 mg/m^2 Bendamustine-Rituximab · EG003: Randomized to Pentostatin-Rituximab · EG004: Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab

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
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      28
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Allergic reaction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Chills
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dyspnea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Edema face
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Enterocolitis infectious
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypotension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Lung infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Pleural effusion

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      6
      num Events
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      28
      num Events
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      28
      num Events
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      28
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      6
      num Events
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      3
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      28
      num Events
      23
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      28
      num Events
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      5
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      28
      num Events
      15
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      28
      num Events
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Alkaline phosphatase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      28
      num Events
      9
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      28
      num Events
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Allergic reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Allergic rhinitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      28
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Alopecia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
      num Events
      9
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      28
      num Events
      26
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      28
      num Events
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      28
      num Events
      13
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      28
      num Events
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Anorexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anxiety
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Arthralgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      6
      num Events
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
      num Events
      4
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      28
      num Events
      27
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      28
      num Events
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Aspartate aminotransferase increased
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 70 mg/m\^2 for initial tolerability study (closed) Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles 6 participants to bendamustine 70 mg/m\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Non-Randomized to 70 mg/m2 Bendamustine-Rituximab
  2. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 for initial tolerability study (closed) Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 6 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Non-randomized to 90 mg/m^2 Bendamustine-Rituximab
  3. deaths Num Affected
    3
    deaths Num At Risk
    28
    description
    Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 Rituximab: 28 participants Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine:28 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
    id
    EG002
    other Num Affected
    28
    other Num At Risk
    28
    serious Num Affected
    8
    serious Num At Risk
    28
    title
    Randomized to 90 mg/m^2 Bendamustine-Rituximab
  4. deaths Num Affected
    5
    deaths Num At Risk
    28
    description
    Treatment Assignment Code 2 (TAC 2) Rituximab + Pentostatin Pentostatin: 28 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle. Rituximab: Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
    id
    EG003
    other Num Affected
    28
    other Num At Risk
    28
    serious Num Affected
    7
    serious Num At Risk
    28
    title
    Randomized to Pentostatin-Rituximab
  5. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\^2 or Rituxan + Pentostatin After initial tolerability studies are completed. Non-randomize up to 4 total participants to Bendamustine and/or Pentostatin with Rituximab Rituximab 375 mg/m\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 1-4 participants to bendamustine 90 mg/m\^2/day, days 1 and 2 each cycle Pentostatin 1-4 participants to pentostatin 4 mg/m\^2 days 1 and 15 of each cycle. Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended. Diphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended. Epinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Antihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Corticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab. Bronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      6
      num Events
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      28
      num Events
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      28
      num Events
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      28
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      6
      num Events
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      3
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      28
      num Events
      23
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      28
      num Events
      18
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
      num Events
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      5
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      28
      num Events
      15
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      28
      num Events
      7
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Alkaline phosphatase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      28
      num Events
      9
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      28
      num Events
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Allergic reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Allergic rhinitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      28
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Alopecia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
      num Events
      9
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      28
      num Events
      26
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      28
      num Events
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      28
      num Events
      13
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      28
      num Events
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Anorexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anxiety
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Arthralgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      6
      num Events
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
      num Events
      4
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      28
      num Events
      27
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      28
      num Events
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Aspartate aminotransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      28
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Allergic reaction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Chills
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dyspnea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Edema face
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Enterocolitis infectious
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypotension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      28
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Lung infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      28
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Pleural effusion
time Frame
Date treatment consent signed to date off study, approximately 103 months and 19 days; 133 months and 11 days; 111 months and 15 days; 102 months and 25 days; 44 months and 14 days; and 19 months and 2 days for each group respectively.

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Preserved source evidence · Not medical advice