MDACC Study Summary 2003-0591

Study Summary
No. 2003-0591:.......Leukemia......Susan O'Brien......Leukemia

Study Summary Title



Study Summary Number:	2003-0591

Study Title:	Fludarabine, Cyclophosphamide, and Multiple Dose Rituximab as Frontline Therapy in Chronic Lymphocytic Leukemia (CLL)

Physician

New Patient Referral



Name:	Susan O'Brien	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:	713-792-7543 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	1 day every 3 months while on therapy, then 1 day every 6 months

Treatment Agents:	Cyclophosphamide Fludarabine Rituxan	Home Care:	Courses 2-6

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Outpatient 4 days with course 1; subsequent cycles may be administered at home.


Description/ Intervention:	The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide and high-dose rituximab will improve the remission rate and the length of remissions in patients with CLL.

Study Objectives / Outcomes

Primary
To evaluate the efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL.

Secondary
To evaluate remission duration and survival.

Study Status Information



Study Activation / Registration Date:	12/31/2003

IRB Review and Approval Date:	12/03/2003

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	66

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) 16 years or older

2) Untreated CLL with indication for therapy or minimally treated (e.g. less than 1 month of steroids or chemotherapy) are eligible

3) Performance status of 3 or better (Appendix A)

4) Adequate renal and hepatic function (creatinine <2 mg%, bilirubin <2mg%). Patient with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman but upper limits for creatinine even under these circumstances would be creatinine < 3 mg% and bilirubin < 6 mg%. Patients with Gilbert's Syndrome may be entered on study with bilirubin 2-7 mg%..

5) A signed informed consent in keeping with policies of the hospital

Exclusion Criteria:

1) None

Links

Registration Number: NCT00794820
Study Information on Clinical Trials Registry (clinicaltrials.gov)