Overview

This trial is active, not recruiting.

Conditions chronic lymphocytic leukemia, leukemia
Treatments fludarabine, cyclophosphamide, rituximab
Phase phase 2
Target CD20
Sponsor M.D. Anderson Cancer Center
Start date August 2008
End date August 2018
Trial size 300 participants
Trial identifier NCT00759798, 2008-0431, 246915, NCI-2012-01663

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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)
fludarabine Fludara®
25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
cyclophosphamide Cytoxan®
250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
rituximab Rituxan®
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)

Primary Outcomes

Measure
Complete Remission Rate (CRR)
time frame: After 6 months

Eligibility Criteria

Male or female participants at least 16 years old.

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:

Additional Information

Official title Prospective Identification of Significant Prognostic Factors in Patients Treated With Fludarabine, Cyclophosphamide, and Rituximab (FCR) as Initial Therapy for Chronic Lymphocytic Leukemia.
Principal investigator William Wierda, M.D.
Description The Study Drugs: Fludarabine is designed to make cancer cells less able to repair damaged DNA (the genetic material of cells). This may increase the likelihood of the cells dying. Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. Rituximab is designed to attach to lymphoma cells, which may cause them to die. Study Drug Administration: Each cycle is 4-6 weeks. If you are found to be eligible to take part in this study, on Day 1 of each cycle, you will receive rituximab through a needle into your vein over 6-8 hours. On Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond, you will receive fludarabine by vein over 30 minutes. You will also receive cyclophosphamide by vein over 30 minutes. You will receive drugs (such as Tylenol, Benadryl, Zofran, allopurinol, and Valtrex) to help prevent side effects. If you have side effects while receiving rituximab, you may be monitored by the study staff for 2 hours after each dose. Study Visits: Once a week, blood (about 1 tablespoon) will be drawn for routine tests. After 3 months (3 cycles of treatment), the following tests and procedures will be performed: - You will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests. - You will have a bone marrow aspirate and biopsy to check the status of the disease. Length of Study: You will be on treatment for about 6 months. You will be taken off treatment early if you have intolerable side effects or the disease gets worse. End-of-Treatment Visit: After you are off treatment, you will have an end-of-treatment visit for doctors to learn your overall response to the treatment. The following tests and procedures will be performed: - You will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests. - You will have a bone marrow aspirate and biopsy to check the status of the disease. Long-Term Follow-up: At 6 months after you have finished treatment and then every year from then on, you will have follow-up visits. The following tests and procedures will be performed: - You will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests. - If your doctor thinks it is needed, you will have a bone marrow biopsy and aspirate to check the status of the disease. This is an investigational study. Fludarabine, cyclophosphamide, and rituximab are FDA approved and commercially available for the treatment of CLL. The correlation with response to treatment and the characteristics of the leukemia cells is investigational. Up to 300 patients will take part in this study. All will be enrolled at MD Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.
Location data was received from the National Cancer Institute and was last updated in September 2016.