Status:
RECRUITING
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hairy Cell Leukemia
Recurrent Hairy Cell Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
PRIMARY OBJECTIVES: 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 we...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 10 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00412594
Start Date
June 10 2004
End Date
June 30 2027
Last Update
December 22 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030