Identifying Prognostic Factors in Frontline FCR for Patients With Chronic Lymphocytic Leukemia (CLL) - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00759798

Purpose

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.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia Leukemia	Drug: Fludarabine Drug: Cyclophosphamide Drug: Rituximab	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Identification of Significant Prognostic Factors in Patients Treated With Fludarabine, Cyclophosphamide, and Rituximab (FCR) as Initial Therapy for Chronic Lymphocytic Leukemia.

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Cyclophosphamide Fludarabine Fludarabine phosphate Rituximab

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Complete remission rate [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Repeat response assessments by physical examination, blood counts, and bone marrow evaluation, including for minimal residual disease will be done 6, 12, and 24 months after last treatment course.

Estimated Enrollment:	300
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fludarabine, Cyclophosphamide, Rituximab	Drug: Fludarabine 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Other Name: Fludara® Drug: Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Other Names: Cytoxan® Neosar® Drug: Rituximab 375 mg/m2 given intravenously on Day 1 of Course 1 All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21) Other Name: Rituxan®

Arms

Assigned Interventions

Experimental: Fludarabine, Cyclophosphamide, Rituximab

Drug: Fludarabine

25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.

Other Name: Fludara®

Drug: Cyclophosphamide

250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.

Other Names:

Cytoxan®
Neosar®

Drug: Rituximab

375 mg/m2 given intravenously on Day 1 of Course 1

All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)

Other Name: Rituxan®

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients will have a diagnosis of CLL, SLL, or CD20 positive low-grade lymphoproliferative disorder.
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.
Patients must have an ECOG performance status of 0-3.
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.
Patients may not receive other concurrent chemotherapy, radiotherapy, or immunotherapy. Localized radiotherapy to an area not compromising bone marrow function does not apply.
Patients must be 16 years of age or older.
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:

- None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759798

Contacts

Contact: William Wierda, M.D.

713/745-0428

wwierda@mdanderson.org

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: William Wierda, M.D. 713-745-0428 wwierda@mdanderson.org

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

William Wierda, M.D.

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00759798 History of Changes
Other Study ID Numbers:	2008-0431
Study First Received:	September 24, 2008
Last Updated:	February 1, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Chronic Lymphocytic Leukemia
Leukemia
FCR

Fludarabine
Cyclophosphamide
Rituximab

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine monophosphate
Rituximab
Fludarabine

Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 23, 2012