Return to List
Study Summary
No.
ID99-338:
.......
Leukemia
......
Michael J. Keating
......
Leukemia
.
Study Summary Title
Study Summary
Number:
ID99-338
Study Title:
A Phase II Study of Fludarabine, Cyclophosphamide, and Rituxan as Therapy in Chronic Lymphocytic Leukemia
.
Physician
New Patient Referral
Name:
Michael J. Keating
Patients Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:
Leukemia
Referring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:
713-745-2376
Contact us about clinical trials
.
General Information
Disease Group:
Leukemia
Supported By:
N/A
Phase of Study:
Phase II
Return
Visit:
Each three months.
Treatment
Agents:
Cyclophosphamide
Fludarabine
Rituximab
Home Care:
N/A
Treatment Loc:
Only at MDACC
Estimated
Length of Stay
in Houston:
All out-patient. Hospitalization rare.
Description/
Intervention:
The goal of this clinical research study is to learn if the new drug Rituxan®,
given with fludarabine and cyclophosphamide, can improve chronic lymphocytic
leukemia. The safety of the combination will also be studied.
.
Study Objectives / Outcomes
To evaluate the therapeutic efficacy and toxicity of fludarabine combined with cyclophosphamide and Rituxan
Ò
as salvage therapy for patients with CLL.
To determine the complete response (CR) and overall response rate (CR+PR) to cyclophosphamide and Rituxan
Ò
as therapy in previously treated patients with CLL.
To evaluate the PCR status for Ig gene rearrangement in responding patients.
.
Study Status Information
Study Activation / Registration Date:
11/29/1999
IRB Review and Approval Date:
11/17/1999
Study Type:
Therapeutic
Recruitment Status:
Terminated
Projected Accrual:
N/A
.
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 with Rai stage III-IV or Rai stage 0-II who meet one or more criteria for active disease as defined by the NCI-sponsored Working Group.
2) Patients must have a performance status of Zubrod 3 or better.
3) Patients must have adequate renal and hepatic function (creatinine <2mg% bilirubin <2mg%). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman.
4) Patients must be 16 years of age or older.
5) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
Exclusion Criteria:
1) Patients may not receive other concurrent chemotherapy, radiotherapy, or immunotherapy. Localized radiotherapy to an area not compromising bone marrow function does not apply.
.
Links
Registration Number:
Not Registered
Other Links:
.
Results
Return to Clinical Trials at M.D. Anderson Cancer Center