Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
NCT ID: NCT00412594
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2004-06-10
2027-06-30
Brief Summary
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Detailed Description
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I. To demonstrate the efficacy in achieving complete response of combination of cladribine administered intravenously over 2 hours for 5 days followed by rituximab weekly for 8 weeks in patients with untreated or previously treated hairy cell leukemia.
II. To examine the efficacy of rituximab to eradicate minimal residual disease (MRD) after cladribine therapy (as assessed by immunophenotyping of bone marrow and peripheral blood).
III. To examine the effect of addition of rituximab to cladribine on the long term disease-free (DFS) and overall survival (OS) (as compared with historical controls).
IV. To evaluate potential predictors of outcome including molecular and flow evaluations of MRD, as well as other potential molecular predictors such as v-raf murine sarcoma viral oncogene homolog B1 (BRAF).
OUTLINE:
Patients receive cladribine intravenously (IV) over 2 hours once daily (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.
After completion of study treatment, patients are followed up every 3 months for 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (cladribine and rituximab)
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.
Cladribine
Given IV
Laboratory Biomarker Analysis
Correlative studies
Rituximab
Given IV
Interventions
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Cladribine
Given IV
Laboratory Biomarker Analysis
Correlative studies
Rituximab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Farhad Ravandi-Kashani
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Farhad Ravandi-Kashani, MD
Role: primary
References
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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.
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2012-01394
Identifier Type: REGISTRY
Identifier Source: secondary_id
2004-0223
Identifier Type: OTHER
Identifier Source: secondary_id
2004-0223
Identifier Type: -
Identifier Source: org_study_id