- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00049413
Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
Pentostatin, Cyclophosphamide And Rituximab (PCR) For B-Cell Chronic Lymphocytic Leukemia (CLL) And Small B-Cell Lymphocytic Lymphoma (SLL): Four Phase II Trials With Patient Stratification Based On Prior Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and cyclophosphamide with rituximab in treating patients who have chronic lymphocytic leukemia or lymphocytic lymphoma.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the efficacy of pentostatin, cyclophosphamide, and rituximab, in terms of response rate, time to treatment failure, time to disease progression, durability of response, and overall survival, in patients with B-cell chronic lymphocytic leukemia or small B-cell lymphocytic lymphoma.
- Determine the safety of this regimen, in terms of acute, subacute, and chronic toxicity, in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (no prior chemotherapy for chronic lymphocytic leukemia vs prior purine analog-based therapy [fludarabine or cladribine] but no alkylator therapy vs prior alkylator-based therapy [chlorambucil or cyclophosphamide] but no prior purine analog therapy vs prior therapy with alkylators and purine analogs, but not as combination therapy).
- First course: Patients receive rituximab IV over 1-4 hours on days 1-3 and pentostatin IV over 10-30 minutes and cyclophosphamide IV over 30-60 minutes on day 1.
- All subsequent courses: Patients receive rituximab IV over 60 minutes, pentostatin IV over 10-30 minutes, and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 160-240 patients (40-60 per stratum) will be accrued for this study.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
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Newport Beach, California, United States, 92658
- Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of B-cell chronic lymphocytic leukemia (CLL) or small B-cell lymphocytic lymphoma (SLL) with the following:
Lymph node biopsy interpreted as SLL or consistent with CLL or all of the following:
- Peripheral lymphocyte count greater than 5,000/mm^3 with small to moderate peripheral lymphocytes and no more than 55% prolymphocytes
- Bone marrow aspirate containing at least 30% lymphoid cells
Immunophenotypic evaluation of peripheral blood lymphocytes demonstrating monoclonality of B lymphocytes with all of the following:
- CD19 or CD20 coexpressed with CD5 antigen in the absence of other pan-T- cell markers (e.g., CD2 or CD3)
- Expression of CD23 on CLL cells or Dim B-cell expression of kappa or lambda light chains
Measurable disease with any of the following:
- 1 or more lymph nodes at least 1.5 cm by CT scan
- Splenomegaly by CT scan
- Peripheral lymphocyte count greater than 5,000/mm3 with coexpression of CD5 and B-cell markers
- Bone marrow aspirate with at least 30% lymphoid cells
- No mantle cell lymphoma
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 2 years
Hematopoietic
- See Disease Characteristics
- No immune thrombocytopenia
- No hemolytic anemia
Hepatic
- Bilirubin no greater than 3 times upper limit of normal (ULN)
- SGOT no greater than 3 times ULN (unless due to hemolysis or CLL)
- No hepatitis
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- No cardiac dysfunction
- No New York Heart Association class III or IV heart disease
- No myocardial infarction within the past month
Other
- HIV negative
- No active acute or chronic infection
- No immunosuppressive diseases
- No autoimmune disorder
- No secondary malignancy that is projected to limit life expectancy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Chemotherapy
- No prior rituximab
- At least 4 weeks since prior biologic therapy
Chemotherapy
- At least 4 weeks since prior chemotherapy
- No prior combination chemotherapy and rituximab or other antibody therapy
- No prior combination chemotherapy comprising an alkylating agent and a purine nucleoside analog (i.e., cyclophosphamide or chlorambucil in combination with fludarabine, cladribine, or pentostatin)
- No prior pentostatin
Endocrine therapy
- At least 4 weeks since prior corticosteroids
- No concurrent supra-physiologic doses of corticosteroids
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- At least 4 weeks since prior major surgery
Other
- No concurrent immunosuppressive therapy (e.g., cyclosporine)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Robert O. Dillman, MD, FACP, Hoag Memorial Hospital Presbyterian
Study record dates
Study Major Dates
Study Start
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- B-cell chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- noncontiguous stage II small lymphocytic lymphoma
- recurrent small lymphocytic lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage IV small lymphocytic lymphoma
- contiguous stage II small lymphocytic lymphoma
- refractory chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Lymphoma
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Immunological
- Adenosine Deaminase Inhibitors
- Cyclophosphamide
- Rituximab
- Pentostatin
Other Study ID Numbers
- CDR0000258096
- CBRG-NIP-0201
- NCI-V02-1712
- SUPEREN-CBRG-NIP-0201
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.
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