Identifying Prognostic Factors in Frontline FCR for Patients With Chronic Lymphocytic Leukemia (CLL)
This study is currently recruiting participants.
Verified January 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00759798
First received: September 24, 2008
Last updated: January 23, 2013
Last verified: January 2013
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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:
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 2015 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fludarabine, Cyclophosphamide, Rituximab
Fludarabine 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. 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) |
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:
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:
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: | January 23, 2013 |
| 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 Vidarabine |
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 Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 23, 2013