Trial · NCT00923013
Cladribine With Simultaneous or Delayed Rituximab to Treat Hairy Cell Leukemia
NCT00923013, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cladribine With Simultaneous or Delayed Rituximab to Treat Hairy Cell Leukemia. Trials, record NCT00923013. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00923013
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cladribine With Simultaneous or Delayed Rituximab to Treat Hairy Cell Leukemia
- NCT number
- NCT00923013
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 175 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Hairy Cell Leukemia
- Interventions
- Cladribine, Rituximab, BMbx, MRI, EKG, Echocardiogram, Abdominal/splenic ultrasound, Stress test
- First posted
- 2009-06-18
- Last updated
- 2026-08-18
- Results first posted
- 2025-08-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate Comparing Minimal Residual Disease (MRD) at 6 Months After Start of Treatment in Comparison Groups | Restaged 6 months after the start of treatment | 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. |
| Secondary | Minimal Residual Disease (MRD)-Free Survival After Cladribine and up to 2 Courses of Rituximab | Testing done 6 months post first dose of treatment, then yearly x2 years and then every 2 years after cladribine indefinitely | 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. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAEv3.0) | 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. | 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 ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate Comparing Minimal Residual Disease (MRD) at 6 Months After Start of Treatment in Comparison Groups | Restaged 6 months after the start of treatment | 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. | Percentage of participants | NUMBER |
| SECONDARY | Minimal Residual Disease (MRD)-Free Survival After Cladribine and up to 2 Courses of Rituximab | Testing done 6 months post first dose of treatment, then yearly x2 years and then every 2 years after cladribine indefinitely | |||
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAEv3.0) | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate Comparing Minimal Residual Disease (MRD) at 6 Months After Start of Treatment in Comparison Groups | Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab | 97.1 | Percentage of participants | ||
| Response Rate Comparing Minimal Residual Disease (MRD) at 6 Months After Start of Treatment in Comparison Groups | Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab | 62.5 | Percentage of participants | ||
| Response Rate Comparing Minimal Residual Disease (MRD) at 6 Months After Start of Treatment in Comparison Groups | Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 23.5 | Percentage of participants | ||
| Response Rate Comparing Minimal Residual Disease (MRD) at 6 Months After Start of Treatment in Comparison Groups | Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 3.3 | Percentage of participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAEv3.0) | Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab | 34 | Participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAEv3.0) | Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab | 31 | Participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAEv3.0) | Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 34 | Participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAEv3.0) | Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 29 | Participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAEv3.0) | Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1) | 24 | Participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAEv3.0) | Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine | 19 | Participants |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab | 34 | |
| Overall Study | STARTED | Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab | 32 | |
| Overall Study | STARTED | Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 34 | |
| Overall Study | STARTED | Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 30 | |
| Overall Study | STARTED | Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1) | 25 | |
| Overall Study | STARTED | Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine | 20 | |
| Overall Study | Disease Progression on Study | Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab | 1 | |
| Overall Study | Disease Progression on Study | Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab | 0 | |
| Overall Study | Disease Progression on Study | Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 0 | |
| Overall Study | Disease Progression on Study | Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,122
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 | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab | 14 | 34 | 16 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab | 3 | 32 | 4 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 9 | 34 | 10 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 5 | 30 | 5 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1) | 4 | 25 | 4 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine | 3 | 20 | 3 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab | 12 | 34 | 13 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab | 3 | 32 | 3 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 10 | 34 | 11 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 2 | 30 | 2 |
1 to 10 of 1,122Source ClinicalTrials.gov
See all 1,122 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab | 2 | 34 |
| Total, all-cause mortality | Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab | 2 | 32 |
| Total, all-cause mortality | Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 0 | 34 |
| Total, all-cause mortality | Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 1 | 30 |
| Total, all-cause mortality | Cohort 2 Arm 3 SubGroup 1-Cladribine (Rituximab Before 1st of 5 Daily Doses of Cladribine on Day 1) | 0 | 25 |
| Total, all-cause mortality | Cohort 3Arm3 HairyCell LeukemiaVariant-Cladribine +(Rituximab Before 1st of 5 Daily Doses Cladribine | 5 | 20 |
| Total, other adverse events | Cohort 1 Arm 1 SubGroup 1 -Cladribine + Rituximab | 34 | 34 |
| Total, other adverse events | Cohort 1 Arm 1 SubGroup 2 -Cladribine + Rituximab | 31 | 32 |
| Total, other adverse events | Cohort 1 Arm 2 SubGroup 1-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 34 | 34 |
| Total, other adverse events | Cohort 1 Arm 2 SubGroup 2-Cladribine(+Rituximab After 6 Months if Minimal Residual Disease Detected) | 29 | 30 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers5
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/NCT00923013
GET https://conductscience.org/api/trials/v1/NCT00923013/flow?page=2