MDACC Study Summary 2008-0431

Study Summary
No. 2008-0431:.......Leukemia......William G. Wierda......Leukemia

Study Summary Title



Study Summary Number:	2008-0431

Study Title:	Prospective Identification of Significant Prognostic Factors in Patients Treated with Fludarabine, Cyclophosphamide, and Rituximab (FCR) as Initial Therapy for Chronic Lymphocytic Leukemia.

Physician

New Patient Referral



Name:	William G. Wierda	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:	713-745-0428 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	After completion of treatmet, patients with return to MDACC for follow-up 6, 12, and 24 months later. Follow-up thereafter will be with annual visit until patients relapse or go on alternative treatment.

Treatment Agents:	Acetaminophen Allopurinol Cyclophosphamide Fludarabine Ondansetron Hydrochloride Rituximab Valacyclovir	Home Care:	Patients may receive courses 2-6 at home with their referring physician with interim visits at MDACC before course 4 and after course 6 for response assessments.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn more about the characteristics of CLL, including genes and chromosome abnormalities and proteins expressed by the leukemia cells, which may help doctors predict if patients who receive standard treatment (fludarabine, cyclophosphamide, and rituximab) for the first time will experience a complete remission.

Study Objectives / Outcomes

Primary Objective:
The primary objective of the study is to prospectively evaluate new and traditional prognostic factors and evaluate associations with complete remission (CR) in frontline patients treated with FCR.

Secondary Objectives:

To prospectively evaluate new and traditional prognostic factors and evaluate associations with overall response and time to failure in frontline patients treated with FCR.
To prospectively determine the minimal residual disease (MRD)-free rate in bone marrow of patients treated with frontline FCR and to evaluate prognostic factors for MRD.
To assess the pharmacokinetics of rituximab in patients treated with frontline FCR.

Study Status Information



Study Activation / Registration Date:	08/13/2008

IRB Review and Approval Date:	08/13/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

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) Patients will have a diagnosis of CLL, SLL, or CD20 positive low-grade lymphoproliferative disorder.

2) All patients with untreated Rai stage III-IV are eligible for this protocol. Prior treatment with single-agent rituximab permitted. OR Patients with untreated Rai stage 0-II who meet one or more criteria for active disease as defined by the International Working Group for CLL (IWCLL). Prior treatment with single-agent rituximab permitted.

3) Patients must have an ECOG performance status of 0-3.

4) 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.

5) Patients may not receive other concurrent chemotherapy, radiotherapy, or immunotherapy. Localized radiotherapy to an area not compromising bone marrow function does not apply.

6) Patients must be 16 years of age or older.

7) Patients must sign informed consent indicating that they are aware of the investigational nature of this study according to the policies of the MDACC IRB.

Exclusion Criteria:

N/A

Links

Registration Number: NCT00759798
Study Information on Clinical Trials Registry (clinicaltrials.gov)