Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia
2 other identifiers
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2004
CompletedFirst Submitted
Initial submission to the registry
December 14, 2006
CompletedFirst Posted
Study publicly available on registry
December 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
December 22, 2025
December 1, 2025
23.1 years
December 14, 2006
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Efficacy of rituximab on achievement of complete response after therapy with cladribine
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.
At 12 weeks
Monitoring the related toxicity for the therapy Grade 3-4
Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.
Up to 1 year
Efficacy of rituximab in eradication of minimal residual disease after cladribine therapy, assessed by immunophenotyping of bone marrow and peripheral blood
The method of Thall, Simon, Estey as extended by Thall and Sung will be used for efficacy and safety monitoring.
Up to 4 weeks after the last dose of rituximab
Efficacy of rituximab on prolongation of event-free survival
Up to 1 year
Efficacy of rituximab on prolongation of overall survival
Up to 1 year
Study Arms (1)
Treatment (cladribine and rituximab)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Age 18 years and older
- Diagnosis of hairy cell leukemia (HCL) established by bone marrow examination
- Patients with relapsed disease are eligible if they have had no more than one prior therapy
- Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study
- Performance status =\< 3
- Creatinine less than or equal to 2.0 unless related to the disease
- Bilirubin less than or equal to 3.0
- Transaminases less than or equal 3 x upper limit of normal unless related to the disease
- No prior investigational agent in the 4 weeks prior to initiation of therapy
You may not qualify if:
- Unable or unwilling to sign the consent form
- Known infection with human immunodeficiency virus (HIV), hepatitis B or C
- Presence of active infection
- Presence of central nervous system (CNS) metastases
- New York Heart Association classification III or IV heart disease
- Prior chemotherapy (last 4 weeks)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Ravandi F, O'Brien S, Jorgensen J, Pierce S, Faderl S, Ferrajoli A, Koller C, Challagundla P, York S, Brandt M, Luthra R, Burger J, Thomas D, Keating M, Kantarjian H. Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia. Blood. 2011 Oct 6;118(14):3818-23. doi: 10.1182/blood-2011-04-351502. Epub 2011 Aug 5.
PMID: 21821712DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Farhad Ravandi-Kashani
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2006
First Posted
December 18, 2006
Study Start
June 10, 2004
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
December 22, 2025
Record last verified: 2025-12