- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00759798
Identifying Prognostic Factors in Frontline FCR for Patients With Chronic Lymphocytic Leukemia (CLL)
Prospective Identification of Significant Prognostic Factors in Patients Treated With Fludarabine, Cyclophosphamide, and Rituximab (FCR) as Initial Therapy for Chronic Lymphocytic Leukemia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients will have a diagnosis of CLL, Small Lymphocytic Lymphoma (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 Eastern Cooperative Oncology Group (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 MD Anderson Cancer Center Institutional Review Board (MDACC IRB).
Exclusion Criteria:
N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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) |
25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
Other Names:
250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond.
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Complete Remission (CR)
Time Frame: After 6 months
|
Complete Response defined by NCI Working Group / International Working Group for CLL criteria as no evidence of disease on physical examination (no adenopathy or organomegaly) or microscopic examination of blood (ALC <4,000/L) and bone marrow (<30% lymphocytes, no lymphoid nodules), and recovery of hemoglobin, neutrophil, and platelet counts.
|
After 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William Wierda, M.D., M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Immunological
- Cyclophosphamide
- Rituximab
- Fludarabine
Other Study ID Numbers
- 2008-0431
- NCI-2012-01663 (Registry Identifier: NCI CTRP)
- 246915 (Other Grant/Funding Number: Evaluation of Biomarkers for CLL Progression in the p53 Pathway: A Genetic Approach in Mice and Man)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Leukemia
-
Massachusetts General HospitalCelgene CorporationTerminatedAcute Myelogenous Leukemia | Acute Myeloid Leukemia (AML) | Acute Myelocytic Leukemia | Acute Granulocytic Leukemia | Acute Non-Lymphocytic LeukemiaUnited States
-
Stanford UniversityTerminatedLeukemia | Leukemia, Lymphocytic, Acute | Leukemia Acute Promyelocytic Leukemia (APL) | Leukemia Acute Lymphoid Leukemia (ALL) | Leukemia Chronic Myelogenous Leukemia (CML) | Leukemia Acute Myeloid Leukemia (AML) | Leukemia Chronic Lymphocytic Leukemia (CLL)United States
-
Institute of Hematology & Blood Diseases HospitalBejing Institute for Stem Cell and Regenerative Medicine; Institute for Stem...RecruitingRefractory Leukemia | Relapsed Leukemia | Acute Myeloid Leukemia, ChildhoodChina
-
Betta Pharmaceuticals Co., Ltd.Not yet recruitingAcute Myeloid Leukemia LeukemiaChina
-
Center for International Blood and Marrow Transplant...National Marrow Donor Program; St. Baldrick's FoundationActive, not recruitingAcute Myelogenous LeukemiaUnited States
-
Massachusetts General HospitalCompleted
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid MalignanciesUnited States
-
Hybrigenics CorporationUnknownAcute Myelogenous LeukemiaUnited States, France
-
Beijing Boren HospitalRecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapse LeukemiaChina
-
National Cancer Institute (NCI)TerminatedAdult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monocytic Leukemia (M5b) | Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloblastic Leukemia Without Maturation... and other conditionsUnited States
Clinical Trials on Fludarabine
-
National Institute of Arthritis and Musculoskeletal...CompletedPsoriasis | Arthritis, PsoriaticUnited States
-
Nantes University HospitalCyceronNot yet recruiting
-
Emory UniversityCompletedSickle Cell Disease | Bone Marrow TransplantationUnited States
-
Naoyuki G. Saito, M.D., Ph.D.WithdrawnAcute Myeloid Leukemia | Myelodysplastic Syndromes | Chronic Myeloid Leukemia | Acute Lymphocytic LeukemiaUnited States
-
National Institute of Arthritis and Musculoskeletal...CompletedSystemic Lupus Erythematosus | Glomerulonephritis | Lupus NephritisUnited States
-
University Hospital, CaenCNRS, UMR ISTCT 6301, LDM-TEP Groupe, GIP Cyceron, Caen, FranceCompletedUntreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma PatientsFrance
-
University of Illinois at ChicagoCompletedAcute Myeloid Leukemia | Polycythemia Vera | Multiple Myeloma | Myelofibrosis | Acute Leukemia | Chronic Myelogenous Leukemia | Aplastic Anemia | Myeloproliferative Disorder | Hodgkin's Disease | Malignant Lymphoma | Lymphocytic LeukemiaUnited States
-
Massachusetts General HospitalTerminatedMultiple Myeloma | Hodgkin Disease | Non Hodgkin's LymphomaUnited States
-
Zhujiang HospitalFirst Affiliated Hospital, Sun Yat-Sen University; Nanfang Hospital of Southern... and other collaboratorsUnknownLeukemia Relapse | Chronic Graft-versus-host-disease
-
German CLL Study GroupCompletedAnemia | Chronic Lymphocytic LeukemiaGermany