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← Hairy Cell Leukemia

NCT00923013 · STUDY IN CONTEXT

Cladribine With Simultaneous or Delayed Rituximab to Treat Hairy Cell Leukemia

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

exploratory · POSTED

Here is the number of participants with serious and/or non-serious adverse events (AE's) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Source null

→

primary · POSTED

Participants with newly diagnosed Hairy Cell Leukemia (HCL) and once relapsed HCL were split and both groups were randomized to receive either simultaneous treatment with Cladribine and Rituxan or Cladribine with Rituxan given no earlier than 6 months after cladribine as needed. Outcome measured by Bone Marrow and Blood Flow cytometry and histochemistry of the core biopsy at the 6 months after start of treatment time point. If all three were negative for hairy cells participants were in a minimal residual disease status (MRD). And were considered without HCL disease at that time point.

Cohort 2, Arm 3 and Cohort 3, Arm 3 are not reported because the investigator is only comparing the randomized groups. The primary goal is comparing the randomization and Cohort 2 was not randomized.

→

secondary · NOT_POSTED

Compare Cladribine + Rituxan vs cladribine alone in terms of MRD-free survival. MRD free survival time is the time until relapsing from MRD to -free to Complete response. Measured by blood and bone marrow flow cytometry, complete blood count (CBC), and bone marrow immunohistochemistry.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-hairy-cell-leukemia
nct id
NCT00923013
trial label
Cladribine With Simultaneous or Delayed Rituximab to Treat Hairy Cell Leukemia
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
3
harms Count
6
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0002
    source section id
    NCT00923013-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAEv3.0)
    endpoint definition
    Here is the number of participants with serious and/or non-serious adverse events (AE's) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
    time origin
    From first study intervention,Study Day 1, Cycle 1-30 days after study agent up to day 35 for participants receiving cladribine only, up to day 80 for participants receiving cladribine+rituximab, &up to day 80 for participants receiving delayed rituximab.
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0000
    source section id
    NCT00923013-om-0000
    source outcome index
    0
    endpoint
    Response Rate Comparing Minimal Residual Disease (MRD) at 6 Months After Start of Treatment in Comparison Groups
    endpoint definition
    Participants with newly diagnosed Hairy Cell Leukemia (HCL) and once relapsed HCL were split and both groups were randomized to receive either simultaneous treatment with Cladribine and Rituxan or Cladribine with Rituxan given no earlier than 6 months after cladribine as needed. Outcome measured by Bone Marrow and Blood Flow cytometry and histochemistry of the core biopsy at the 6 months after start of treatment time point. If all three were negative for hairy cells participants were in a minimal residual disease status (MRD). And were considered without HCL disease at that time point.
    time origin
    Restaged 6 months after the start of treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Cohort 2, Arm 3 and Cohort 3, Arm 3 are not reported because the investigator is only comparing the randomized groups. The primary goal is comparing the randomization and Cohort 2 was not randomized.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0001
    source section id
    NCT00923013-om-0001
    source outcome index
    1
    endpoint
    Minimal Residual Disease (MRD)-Free Survival After Cladribine and up to 2 Courses of Rituximab
    endpoint definition
    Compare Cladribine + Rituxan vs cladribine alone in terms of MRD-free survival. MRD free survival time is the time until relapsing from MRD to -free to Complete response. Measured by blood and bone marrow flow cytometry, complete blood count (CBC), and bone marrow immunohistochemistry.
    time origin
    Testing done 6 months post first dose of treatment, then yearly x2 years and then every 2 years after cladribine indefinitely
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab
    regimen
    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 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00923013-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab
    regimen
    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 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.
    analyzed count
    32
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00923013-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
    regimen
    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 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00923013-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
    regimen
    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 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00923013-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab
    regimen
    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 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00923013-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab
    regimen
    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 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine + Rituximab.
    analyzed count
    32
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00923013-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
    regimen
    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 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00923013-om-0002#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0002
    arm key
    OG003
    arm label
    Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
    regimen
    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 (randomization stratified based upon prior purine analog \[yes/no\]). Cladribine (+ Rituximab after 6 months if minimal residual disease (MRD) detected).
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00923013-om-0002#groups/OG003
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0002
    arm key
    OG004
    arm label
    Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1)
    regimen
    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
    analyzed count
    25
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00923013-om-0002#groups/OG004
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    outcome key
    om-0002
    arm key
    OG005
    arm label
    Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine
    regimen
    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
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00923013-om-0002#groups/OG005
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    harm key
    EG000
    source section id
    NCT00923013-ae
    event group key
    EG000
    event group label
    Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab
    serious affected
    4
    serious at risk
    34
    other affected
    34
    other at risk
    34
    frequency threshold
    0
    collection period
    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.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    harm key
    EG001
    source section id
    NCT00923013-ae
    event group key
    EG001
    event group label
    Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab
    serious affected
    2
    serious at risk
    32
    other affected
    31
    other at risk
    32
    frequency threshold
    0
    collection period
    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.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    harm key
    EG002
    source section id
    NCT00923013-ae
    event group key
    EG002
    event group label
    Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
    serious affected
    2
    serious at risk
    34
    other affected
    34
    other at risk
    34
    frequency threshold
    0
    collection period
    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.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    harm key
    EG003
    source section id
    NCT00923013-ae
    event group key
    EG003
    event group label
    Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected)
    serious affected
    5
    serious at risk
    30
    other affected
    29
    other at risk
    30
    frequency threshold
    0
    collection period
    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.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    harm key
    EG004
    source section id
    NCT00923013-ae
    event group key
    EG004
    event group label
    Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1)
    serious affected
    4
    serious at risk
    25
    other affected
    24
    other at risk
    25
    frequency threshold
    0
    collection period
    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.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hairy-cell-leukemia
    nct id
    NCT00923013
    harm key
    EG005
    source section id
    NCT00923013-ae
    event group key
    EG005
    event group label
    Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine
    serious affected
    3
    serious at risk
    20
    other affected
    19
    other at risk
    20
    frequency threshold
    0
    collection period
    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.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice