CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 150 target
Drug / intervention
Cladribine +2 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • Age 18 years or older
  • Diagnosis of hairy cell leukemia confirmed by bone marrow examination
  • Relapsed HCL allowed with no more than one prior therapy
  • Women of childbearing potential must use contraception during study
Key exclusion· 6
  • Unable or unwilling to sign consent form
  • Known HIV, hepatitis B, or hepatitis C infection
  • Presence of active infection
  • CNS metastases present

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00412594
NCT00412594Phase 2RecruitingOn Track
Long Recruiting

Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia

M.D. Anderson Cancer Center·interventional·Posted Dec 18, 2006·Updated Jun 11, 2026

In Brief

A Phase 2 clinical trial evaluating Cladribine, Laboratory Biomarker Analysis, and 1 other intervention for Hairy Cell Leukemia and Recurrent Hairy Cell Leukemia. Currently recruiting, targeting 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2Recruiting
2004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
First PostedDec 18, 2006
Enrollment StartJun 10, 2004
Primary CompletionJun 30, 2027
TodayJul 2, 2026
Enrollment to primary: 23.1 yearsPosted 19.5 years agoPrimary completion in 12 months

Arms & Interventions

Treatment (cladribine and rituximab)experimental

Patients receive cladribine IV over 2 hours QD on days 1-5 and rituximab IV once weekly for 8 weeks beginning on day 28 in the absence of disease progression or unacceptable toxicity.

Drug: CladribineOther: Laboratory Biomarker AnalysisBiological: Rituximab

Interventions

Cladribinedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Rituximabbiological

Given IV