Trial · NCT01059786
Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia
NCT01059786, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2024-05-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia. Trials, record NCT01059786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01059786
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia
- NCT number
- NCT01059786
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 69 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Hairy Cell Leukemia
- Interventions
- Pentostatin, Rituximab, Bendamustine, Acetaminophen, Diphenhydramine, Epinephrine, Antihistamines, Corticosteroids, Bronchodilators, Intravenous (IV) Saline
- First posted
- 2010-02-01
- Last updated
- 2026-10-15
- Results first posted
- 2024-05-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) | At end of treatment, approximately 6 months | 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. |
| Secondary | Pentostatin + Rituximab and Bendamustine + Rituximab in Crossover When Used After Failure of the 1st Regimen | 4 years | Compare the 2 regimens - pentostatin + rituximab and bendamustine + rituximab in crossover when used after failure of the 1st regimen. |
| Secondary | Response Rate | 4 years | 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 |
| Secondary | Mechanism of Thrombocytopenia | 4 years | The mechanism of thrombocytopenia after purine analog plus rituximab. |
| Secondary | Hairy Cell Leukemia (HCL) Biology | 4 years | HCL biology was determined by cloning, sequencing and characterizing monoclonal immunoglobulin rearrangements, and other genes. |
| Secondary | Correlation of Measurable Residual Disease (MRD) Levels and Tumor Markers With Response | 4 years | 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. |
| Secondary | Measurable Residual Disease (MRD)-Free Survival | 4 years | MRD-free survival is defined by the Response criteria. |
| Secondary | Disease-free Survival (DFS) | time from start of treatment to documented evidence of disease progression | Disease-free survival is the time from start of treatment to documented evidence of disease progression measured by the following response criteria. Progressive disease ≥50% increase in sum of products of perpendicular diameters of evaluable (\> 2cm) lymphadenopathy or appearance of new evaluable lymph nodes \>2cm. |
| Secondary | Overall Survival | time between the first day of treatment to the day of death | OS is the time between the first day of treatment to the day of death. |
| Secondary | Grade 3 and/or 4 Toxicity | 4 years | Toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) | At end of treatment, approximately 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pentostatin + Rituximab and Bendamustine + Rituximab in Crossover When Used After Failure of the 1st Regimen | 4 years | |||
| SECONDARY | Response Rate | 4 years | |||
| SECONDARY | Mechanism of Thrombocytopenia | 4 years | |||
| SECONDARY | Hairy Cell Leukemia (HCL) Biology | 4 years | |||
| SECONDARY | Correlation of Measurable Residual Disease (MRD) Levels and Tumor Markers With Response | 4 years | |||
| SECONDARY | Measurable Residual Disease (MRD)-Free Survival | 4 years | |||
| SECONDARY | Disease-free Survival (DFS) | time from start of treatment to documented evidence of disease progression | |||
| SECONDARY | Overall Survival | time between the first day of treatment to the day of death | |||
| SECONDARY | Toxicity | 4 years |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) | Non-Randomized to 70 mg/m2 Bendamustine-Rituximab | Complete Remission | 3 | Participants | |
| Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) | Non-randomized to 90 mg/m^2 Bendamustine-Rituximab | Complete Remission | 4 | Participants | |
| Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) | Randomized to 90 mg/m^2 Bendamustine-Rituximab | Complete Remission | 20 | Participants | |
| Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) | Randomized to Pentostatin-Rituximab | Complete Remission | 22 | Participants | |
| Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) | Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab | Complete Remission | 1 | Participants | |
| Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) | Non-Randomized to 70 mg/m2 Bendamustine-Rituximab | Partial Response | 3 | Participants | |
| Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) | Non-randomized to 90 mg/m^2 Bendamustine-Rituximab | Partial Response | 2 | Participants | |
| Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) | Randomized to 90 mg/m^2 Bendamustine-Rituximab | Partial Response | 4 | Participants | |
| Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) | Randomized to Pentostatin-Rituximab | Partial Response | 4 | Participants | |
| Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR) | Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab | Partial Response | 0 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Non-Randomized to 70 mg/m2 Bendamustine-Rituximab | 6 | |
| Overall Study | STARTED | Non-randomized to 90 mg/m^2 Bendamustine-Rituximab | 6 | |
| Overall Study | STARTED | Randomized to 90 mg/m^2 Bendamustine-Rituximab | 28 | |
| Overall Study | STARTED | Randomized to Pentostatin-Rituximab | 28 | |
| Overall Study | STARTED | Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab | 1 | |
| Overall Study | COMPLETED | Non-Randomized to 70 mg/m2 Bendamustine-Rituximab | 6 | |
| Overall Study | COMPLETED | Non-randomized to 90 mg/m^2 Bendamustine-Rituximab | 6 | |
| Overall Study | COMPLETED | Randomized to 90 mg/m^2 Bendamustine-Rituximab | 24 | |
| Overall Study | COMPLETED | Randomized to Pentostatin-Rituximab | 27 | |
| Overall Study | COMPLETED | Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events935
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Non-Randomized to 70 mg/m2 Bendamustine-Rituximab | 5 | 6 | 10 |
| other | Abdominal pain | Gastrointestinal disorders | Non-randomized to 90 mg/m^2 Bendamustine-Rituximab | 2 | 6 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Randomized to 90 mg/m^2 Bendamustine-Rituximab | 5 | 28 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Randomized to Pentostatin-Rituximab | 5 | 28 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab | 0 | 1 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Non-Randomized to 70 mg/m2 Bendamustine-Rituximab | 0 | 6 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Non-randomized to 90 mg/m^2 Bendamustine-Rituximab | 0 | 6 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Randomized to 90 mg/m^2 Bendamustine-Rituximab | 1 | 28 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | Randomized to Pentostatin-Rituximab | 1 | 28 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab | 0 | 1 | 0 |
1 to 10 of 935Source ClinicalTrials.gov
See all 935 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non-Randomized to 70 mg/m2 Bendamustine-Rituximab | 0 | 6 |
| Total, all-cause mortality | Non-randomized to 90 mg/m^2 Bendamustine-Rituximab | 0 | 6 |
| Total, all-cause mortality | Randomized to 90 mg/m^2 Bendamustine-Rituximab | 3 | 28 |
| Total, all-cause mortality | Randomized to Pentostatin-Rituximab | 5 | 28 |
| Total, all-cause mortality | Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab | 0 | 1 |
| Total, other adverse events | Non-Randomized to 70 mg/m2 Bendamustine-Rituximab | 6 | 6 |
| Total, other adverse events | Non-randomized to 90 mg/m^2 Bendamustine-Rituximab | 6 | 6 |
| Total, other adverse events | Randomized to 90 mg/m^2 Bendamustine-Rituximab | 28 | 28 |
| Total, other adverse events | Randomized to Pentostatin-Rituximab | 28 | 28 |
| Total, other adverse events | Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab | 1 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01059786
GET https://conductscience.org/api/trials/v1/NCT01059786/events?page=2