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Study Summary
No. 2004-0223:.......Leukemia......Farhad Ravandi-Kashani......Leukemia
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Study Summary Title
Study Summary
Number:		2004-0223
Study Title:PHASE II STUDY OF 2-CHLORODEOXYADENOSINE (2CDA) FOLLOWED BY RITUXIMAB IN HAIRY CELL LEUKEMIA
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Physician New Patient Referral
Name:Farhad Ravandi-KashaniPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7305
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Daily for 5 days, then weekly for 8 weeks then every three months for first
year, then every 6 months. Patients can receive their treatment locally after
the first dose of both agents has been administered at M.D. Anderson.
Treatment
Agents:		2-Chlorodeoxyadenosine
Rituximab		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.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		No hospitalization required.
Description/
Intervention:		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.
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Study Objectives / Outcomes
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
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Study Status Information
Study Activation / Registration Date:06/10/2004
IRB Review and Approval Date:05/19/2004
Study Type:Therapeutic
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria: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
Exclusion Criteria: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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Links
Registration Number: NCT00412594
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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