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NCT00412594 · ClinicalTrials.gov registry record · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
A Phase 2 study of Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT00412594: Recruiting Phase 2 study of Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT00412594 is a Phase 2 study of Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 150 participants, above the 63-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (138% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00412594, a Phase 2 study of Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.
Primary Outcome
Defined as the absence of hairy cells in the bone marrow or the presence of less than 1 percent atypical cells and the disappearance of all evidence of hairy cell leukemia on physical examination. Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.
Conditions Studied
Interventions
- DRUG Cladribine
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Rituximab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2004-06-10 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What NCT00412594 shows while recruiting
NCT00412594 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 63-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (138% higher).
The record links to 2 conditions, with Hairy Cell Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Cladribine is the first listed.
NCT00412594 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00412594 about?
NCT00412594 is a clinical study titled "Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia". This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing...
What is the current status of trial NCT00412594?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2004-06-10. Estimated completion is 2027-06-30.
What conditions does trial NCT00412594 study?
This clinical trial studies the following conditions: Hairy Cell Leukemia, Recurrent Hairy Cell Leukemia.
What interventions are being tested in trial NCT00412594?
The interventions under investigation include: Cladribine (DRUG), Laboratory Biomarker Analysis (OTHER), Rituximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00412594?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00412594 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hairy Cell Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00412594's enrollment target sits among peer trials
150 2nd of 15 the highest of 15 other Hairy Cell Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hairy Cell Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)
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-
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