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Study Summary
No. DM02-593:.......Leukemia......William G. Wierda......Leukemia
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Study Summary Title
Study Summary
Number:		DM02-593
Study Title:A Phase II Study of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) in Previously Treated Patients with CLL
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Physician New Patient Referral
Name:William G. WierdaPatients 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:713-745-0428
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Weekly for Cycle 1, then monthly for Cycles 2 - 6, then every three months.
Treatment
Agents:		Campath-1H
Cyclophosphamide
Fludarabine
Rituximab		Home Care:Treatment for Cycles 2 - 6 may be administered by the referring physician per
protocol.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		None
Description/
Intervention:		The goal of this clinical research study is to learn if the combination of
fludarabine, cyclophosphamide, alemtuzumab, and rituximab is effective in
treating chronic lymphocytic leukemia in patients who have already been treated
with chemotherapy.
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Study Objectives / Outcomes
      Primary Objectives
          Evaluate the therapeutic efficacy, including the complete remission (CR), nodular partial remission (NPR), and partial remission (PR) rates (overall response) of combined cyclophosphamide, fludarabine, alemtuzumab, and rituximab (CFAR) in previously treated patients with CLL.
Second Objectives
          Assess the toxicity profile of CFAR in previously treated patients with CLL.

          Monitor for infection and determine incidence and etiology of infection including cytomegalovirus in patients treated with CFAR.

          Evaluate molecular remission by polymerase chain reaction (PCR) for the clonal immunoglobulin heavy chain variable gene in responding patients treated with CFAR.

          Assess immune parameters, including pretreatment, during treatment, and post-treatment blood T-cell counts and
          subset distribution and serum immunoglobulin levels in patients treated with CFAR.
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Study Status Information
Study Activation / Registration Date:12/06/2002
IRB Review and Approval Date:11/06/2002
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:80
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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) All patients must have been diagnosed with CLL by immunophenotyping and flow cytometry analysis of blood or bone marrow demonstrating a monoclonal population of CD5 and CD19 positive cells.

2) All patient must have been previously treated with chemotherapy.

3) All patients with Rai stage III-IV are eligible for treatment with this protocol. - OR - All patients with Rai stage 0-II who meet one or more indication for treatment (Appendix C) as defined by the NCI-sponsored Working Group are eligible for treatment with this protocol.

4) All patients must have a Zubrod performance status of 0-3 (Appendix B)

5) All patients must have adequate renal and hepatic function (serum creatinine <2mg/dL; total bilirubin <2.5mg/dL). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the Principle Investigator and appropriate dose adjustment considered.

6) Patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy. Localized radiotherapy to an area not compromising bone marrow function does not apply, nor do hematopoietic growth factors such as erythropoietin, G-CSF, GM-CSF etc.

7) Patients must not have untreated or uncontrolled life-threatening infection.

8) Patients must sign informed consent.
Exclusion Criteria:1) None
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Links
Registration Number:
Other Links:
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Results

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