PHASE II STUDY OF 2-CHLORODEOXYADENOSINE (2CDA) FOLLOWED BY RITUXIMAB IN HAIRY CELL LEUKEMIA
The goal of this clinical research study is to learn if treatment with 2CDA (cladribine) followed by treatment with rituximab can help to control HCL. The safety of this combination treatment will also be studied.
Disease Group: Leukemia
Treatment Agent: 2-Chlorodeoxyadenosine,Rituximab
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: No hospitalization required.
Return Visit: Daily for 5 days, then weekly for 8 weeks then every three months for first year. Patients can receive their treatment locally after the first dose of both agents has been administered at M.D. Anderson.
Home Care: Patients can receive their 2CDA and Rituximab treatment locally after the first ;dose of both agents has been administered at M.D. Anderson.
1. 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. 2. 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). 3. 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) 4. To evaluate potential predictors of outcome including molecular and flow evaluations of MRD, as well as other potential molecular predictors such as BRAF
IRB Review and Approval Date: MAY 19,2004
Recruitment Status: Open
Projected Accrual: N/A
1) Age 18 years and older
2) Diagnosis of HCL established by bone marrow examination
3) Patients with relapsed disease are eligible if they have had no more than one prior therapy
4) Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study
5) Performance status </= 3
6) Adequate renal function: creatinine less than or equal to 2.0 unless related to the disease
7) Adequate liver function: bilirubin less than or equal to 3.0, transaminases less than or equal 3 x upper limit of normal unless related to the disease
8) No prior investigational agent in the 4 weeks prior to initiation of therapy
1) Unable or unwilling to sign the consent form
2) Known infection with HIV, hepatitis B or C
3) Presence of active infection
4) Presence of CNS metastases
5) New York Heart Association Classification III or IV heart disease (See Appendix I)
6) Prior chemotherapy (last 4 weeks)
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