Identifying Prognostic Factors in Frontline FCR for Patients With Chronic Lymphocytic Leukemia (CLL)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-13

Study Completion Date

2020-07-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fludarabine and Rituximab With or Without Lenalidomide or Cyclophosphamide in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia

NCT00602459

Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia Stage III Chronic Lymphocytic Leukemia +1 more

COMPLETED PHASE2

Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)

NCT00860457

Chronic Lymphocytic Leukemia

COMPLETED PHASE2

Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

NCT00801060

Chronic Lymphocytic Leukemia

TERMINATED PHASE2

FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years

NCT00254410

Chronic Lymphocytic Leukemia

COMPLETED PHASE2

Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia

NCT00281918

Leukemia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Lymphocytic Leukemia Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Fludarabine

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Rituximab

Intervention Type DRUG

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fludarabine

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

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fludara® Cytoxan® Neosar® Rituxan®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients will have a diagnosis of CLL, Small Lymphocytic Lymphoma (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 Eastern Cooperative Oncology Group (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 MD Anderson Cancer Center Institutional Review Board (MDACC IRB).