TriangleNCT01059786 · STUDY IN CONTEXT
Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory 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
Number of participants receiving pentostatin + rituximab and bendamustine + rituximab who achieve a CR +PR measured by the following response criteria. Complete remission is all of the following for at least 4 weeks: absolute neutrophil count ≥ 1500/mm\^3, platelets ≥ 100,000/mm\^3, hemoglobin ≥ 11g/dl, spleen non-palpable below the costal margin, or not below costal margin on computed tomography, and circulating hairy cell leukemia (HCL) cells either non-visible on Wright stain or \< 1% by flow cytometry. Partial response is all of the following for at least 4 weeks: neutrophils ≥ 1,500/µL or 50% improvement over baseline, platelets ≥100,000/µL or 50% improvement over baseline, hemoglobin ≥ 11.0 g/dL or 50% improvement over baseline, ≥ 50% decrease in circulating malignant HCL count from the pretreatment baseline, ≥ 50% reduction in sum of products of perpendicular diameters or decrease to ≤ 2 cm in evaluable (\> 2cm) lymphadenopathy.
Compare the 2 regimens - pentostatin + rituximab and bendamustine + rituximab in crossover when used after failure of the 1st regimen.
Response rate between participants who received rituximab plus either pentostatin or bendamustine measured by the following response criteria. Complete remission is all of the following for at least 4 weeks: absolute neutrophil count ≥ 1500/mm\^3, platelets ≥ 100,000/mm\^3, hemoglobin ≥ 11g/dl, spleen non-palpable below the costal margin, or not below costal margin on computed tomography, and circulating hairy cell leukemia (HCL) cells either non-visible on Wright stain or \< 1% by flow cytometry. Partial response is all of the following for at least 4 weeks: neutrophils ≥ 1,500/µL or 50% improvement over baseline, platelets ≥100,000/µL or 50% improvement over baseline, hemoglobin ≥ 11.0 g/dL or 50% improvement over baseline, ≥ 50% decrease in circulating malignant HCL count from the pretreatment baseline, ≥ 50% reduction in sum of products of perpendicular diameters. Progressive disease is appearance of new evaluable lymph nodes \>2cm. Stable disease is none of the above
The mechanism of thrombocytopenia after purine analog plus rituximab.
HCL biology was determined by cloning, sequencing and characterizing monoclonal immunoglobulin rearrangements, and other genes.
Determine if MRD levels and tumor markers (soluble cluster of Differentiation 25 (CD25) and cluster of differentiation-22 (CD22), and real-time quantitative reverse transcriptase polymerase chain reaction (RQ-PCR) correlate with response and clinical endpoints, and if bone marrow magnetic resonance imaging (MRI) signal correlates with bone marrow biopsy (BMBx) results, and whether these tests could in some cases possibly replace BMBx.
Reported safety
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
- NCT01059786
- trial label
- Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory 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
- 6
- harms Count
- 5
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- outcome key
- om-0000
- source section id
- NCT01059786-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR)
- endpoint definition
- Number of participants receiving pentostatin + rituximab and bendamustine + rituximab who achieve a CR +PR measured by the following response criteria. Complete remission is all of the following for at least 4 weeks: absolute neutrophil count ≥ 1500/mm\^3, platelets ≥ 100,000/mm\^3, hemoglobin ≥ 11g/dl, spleen non-palpable below the costal margin, or not below costal margin on computed tomography, and circulating hairy cell leukemia (HCL) cells either non-visible on Wright stain or \< 1% by flow cytometry. Partial response is all of the following for at least 4 weeks: neutrophils ≥ 1,500/µL or 50% improvement over baseline, platelets ≥100,000/µL or 50% improvement over baseline, hemoglobin ≥ 11.0 g/dL or 50% improvement over baseline, ≥ 50% decrease in circulating malignant HCL count from the pretreatment baseline, ≥ 50% reduction in sum of products of perpendicular diameters or decrease to ≤ 2 cm in evaluable (\> 2cm) lymphadenopathy.
- time origin
- At end of treatment, approximately 6 months
- analysis role
- primary
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- outcome key
- om-0001
- source section id
- NCT01059786-om-0001
- source outcome index
- 1
- endpoint
- Pentostatin + Rituximab and Bendamustine + Rituximab in Crossover When Used After Failure of the 1st Regimen
- endpoint definition
- Compare the 2 regimens - pentostatin + rituximab and bendamustine + rituximab in crossover when used after failure of the 1st regimen.
- time origin
- 4 years
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- outcome key
- om-0002
- source section id
- NCT01059786-om-0002
- source outcome index
- 2
- endpoint
- Response Rate
- endpoint definition
- Response rate between participants who received rituximab plus either pentostatin or bendamustine measured by the following response criteria. Complete remission is all of the following for at least 4 weeks: absolute neutrophil count ≥ 1500/mm\^3, platelets ≥ 100,000/mm\^3, hemoglobin ≥ 11g/dl, spleen non-palpable below the costal margin, or not below costal margin on computed tomography, and circulating hairy cell leukemia (HCL) cells either non-visible on Wright stain or \< 1% by flow cytometry. Partial response is all of the following for at least 4 weeks: neutrophils ≥ 1,500/µL or 50% improvement over baseline, platelets ≥100,000/µL or 50% improvement over baseline, hemoglobin ≥ 11.0 g/dL or 50% improvement over baseline, ≥ 50% decrease in circulating malignant HCL count from the pretreatment baseline, ≥ 50% reduction in sum of products of perpendicular diameters. Progressive disease is appearance of new evaluable lymph nodes \>2cm. Stable disease is none of the above
- time origin
- 4 years
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- outcome key
- om-0003
- source section id
- NCT01059786-om-0003
- source outcome index
- 3
- endpoint
- Mechanism of Thrombocytopenia
- endpoint definition
- The mechanism of thrombocytopenia after purine analog plus rituximab.
- time origin
- 4 years
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- outcome key
- om-0004
- source section id
- NCT01059786-om-0004
- source outcome index
- 4
- endpoint
- Hairy Cell Leukemia (HCL) Biology
- endpoint definition
- HCL biology was determined by cloning, sequencing and characterizing monoclonal immunoglobulin rearrangements, and other genes.
- time origin
- 4 years
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- outcome key
- om-0005
- source section id
- NCT01059786-om-0005
- source outcome index
- 5
- endpoint
- Correlation of Measurable Residual Disease (MRD) Levels and Tumor Markers With Response
- endpoint definition
- Determine if MRD levels and tumor markers (soluble cluster of Differentiation 25 (CD25) and cluster of differentiation-22 (CD22), and real-time quantitative reverse transcriptase polymerase chain reaction (RQ-PCR) correlate with response and clinical endpoints, and if bone marrow magnetic resonance imaging (MRI) signal correlates with bone marrow biopsy (BMBx) results, and whether these tests could in some cases possibly replace BMBx.
- time origin
- 4 years
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Non-Randomized to 70 mg/m2 Bendamustine-Rituximab
- regimen
- 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.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01059786-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Non-randomized to 90 mg/m^2 Bendamustine-Rituximab
- regimen
- 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
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01059786-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Randomized to 90 mg/m^2 Bendamustine-Rituximab
- regimen
- 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.
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01059786-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Randomized to Pentostatin-Rituximab
- regimen
- 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.
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01059786-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab
- regimen
- 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
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01059786-om-0000#groups/OG004
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- harm key
- EG000
- source section id
- NCT01059786-ae
- event group key
- EG000
- event group label
- Non-Randomized to 70 mg/m2 Bendamustine-Rituximab
- serious affected
- 0
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- 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.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- harm key
- EG001
- source section id
- NCT01059786-ae
- event group key
- EG001
- event group label
- Non-randomized to 90 mg/m^2 Bendamustine-Rituximab
- serious affected
- 0
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- 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.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- harm key
- EG002
- source section id
- NCT01059786-ae
- event group key
- EG002
- event group label
- Randomized to 90 mg/m^2 Bendamustine-Rituximab
- serious affected
- 8
- serious at risk
- 28
- other affected
- 28
- other at risk
- 28
- frequency threshold
- 0
- collection period
- 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.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- harm key
- EG003
- source section id
- NCT01059786-ae
- event group key
- EG003
- event group label
- Randomized to Pentostatin-Rituximab
- serious affected
- 7
- serious at risk
- 28
- other affected
- 28
- other at risk
- 28
- frequency threshold
- 0
- collection period
- 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.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hairy-cell-leukemia
- nct id
- NCT01059786
- harm key
- EG004
- source section id
- NCT01059786-ae
- event group key
- EG004
- event group label
- Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 0
- collection period
- 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.
- 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