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NCT00923013 · ClinicalTrials.gov registry record · Phase 2
Cladribine With Simultaneous or Delayed Rituximab to Treat Hairy Cell Leukemia
A Phase 2 study of Hairy Cell Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
- 1
- Study location
NCT00923013 is a Phase 2 study of Hairy Cell Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 175 participants, above the 61-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (187% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00923013, a Phase 2 study of Hairy Cell Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 175 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Hairy cell leukemia (HCL) is highly responsive to but not curable by cladribine (CdA). HCL responds to rituximab, which is not yet standard therapy for HCL. Patients with the interleukin 2 (IL-2) receptor (CD25)-negative hairy cell leukemia variant (HCLv) respond poorly to initial cladribine but do respond to rituximab in anecdotal reports. Deoxycytidine kinase phosphorylates cladribine to chlorodeoxyadenosine triphosphate (CdATP), which incorporates into deoxyribonucleic acid (DNA), leading to DNA strand breaks and inhibition of DNA synthesis. Rituximab is an anti-cluster of differentiation 20 (CD20) monoclonal antibody which induces apoptosis and either complement or antibody dependent cytotoxicity (antibody-dependent cellular cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC). Patients in complete remission (CR) to cladribine have minimal residual disease (MRD) by immunohistochemistry of the bone marrow biopsy (BMBx IHC), a risk for early relapse. Tests for HCL MRD in blood or marrow include flow cytometry fluorescence-activated cell sorting (FACS) or polymerase chain reaction (PCR) using consensus primers. The most sensitive HCL MRD test is real-time quantitative PCR using sequence-specific primers real-time quantitative reverse transcriptase polymerase chain reaction (RQ-PCR). In studies with limited follow-up, MRD detected by tests other than RQ-PCR can be eliminated by rituximab after cladribine in greater than 90 percent of patients, but MRD rates after cladribine alone are unknown. Simultaneous cladribine and rituximab might be superior or inferior to delaying rituximab until detection of MRD. Only 4 HCL-specific trials are listed on Cancer.gov: a phase II trial of cladribine followed 4 weeks later by 8 weekly doses of rituximab, and phase I-II trials of recombinant immunotoxins targeting cluster of differentiation-22 (CD22) (BL22, HA22) and CD25 (LMB-2). Objectives: Primary: To determine if HCL MRD differs at 6 months after
Conditions Studied
Interventions
- DRUG Cladribine
- DRUG Rituximab
- DIAGNOSTIC_TEST MRI
- DIAGNOSTIC_TEST EKG
- PROCEDURE BMbx
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2008-10-20 |
| Est. Completion | 2030-01-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923013
The ClinicalTrials.gov registry entry for NCT00923013 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 61-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (187% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hairy Cell Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cladribine is the first listed.
NCT00923013 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00923013 about?
NCT00923013 is a clinical study titled "Cladribine With Simultaneous or Delayed Rituximab to Treat Hairy Cell Leukemia". Background: Hairy cell leukemia (HCL) is highly responsive to but not curable by cladribine (CdA). HCL responds to rituximab, which is not yet standard therapy for HCL. Patients with the interleukin 2 (IL-2) receptor (CD25)-negative hairy cell leukemia variant (HCLv) respond poorly to initial clad...
What is the current status of trial NCT00923013?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2008-10-20. Estimated completion is 2030-01-31.
What conditions does trial NCT00923013 study?
This clinical trial studies the following conditions: Hairy Cell Leukemia.
What interventions are being tested in trial NCT00923013?
The interventions under investigation include: Cladribine (DRUG), Rituximab (DRUG), MRI (DIAGNOSTIC_TEST), EKG (DIAGNOSTIC_TEST), BMbx (PROCEDURE).
Who is sponsoring clinical trial NCT00923013?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00923013 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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