Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)Primary Mediastinal Large B-cell LymphomaBurkitt LymphomaAnaplastic Large-Cell LymphomaGray Zone Lymphoma
- Interventions
- Drug: EPOCHBiological: Rituximab
- Registration Number
- NCT00001337
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. EPOCH: Etoposide, VP-16, NSC-141540; Prednisone, PRED, NSC-10023; Vincristine, VCR, NSC-67574; Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; with Granulocyte Colony-Stimulating Factor (Amgen), G-CSF, NSC-614629....
- Detailed Description
Background:
The treatment of the intermediate and aggressive non-Hodgkin's lymphomas in adults and children commonly induces complete responses in a sizable fraction of the treated population, and about 2/3 of the complete responders appear to have prolonged disease-free survival.
The present study assesses the activity and tolerability in previously untreated patients of a regimen of EPOCH infusional chemotherapy given intensively with G-CSF support.
Objectives:
Primary:
Assess complete response (CR) and progression-free survival (PFS) of dose-adjusted EPOCH-Rituximab (DA-EPOCH-R) with G-CSF in agressive B-cell lymphomas.
Eligibility:
Non-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma (MGZL) and primary mediastinal B cell lymphoma (PMBL).
Patients greater than or equal to 12 years old.
Any Stage for PMBL and MGZL.
No prior systemic chemotherapy.
HIV negative.
Design:
This study will estimate the complete response rate of a group of previously untreated patients and the extent to which EPOCH infusional drug delivery accompanied by a hematopoietic growth factor can increase the dose intensity of treatment.
Patients receive prednisone orally for 5 days, a 96 hour infusion of vincristine, doxorubicin, and etoposide, and a bolus of cyclophosphamide on day 5.
Cycles are repeated every 21 days for a total of 6-8 cycles.
Patients with CD20 expressing tumors (i.e. mature B-cell lymphomas) will also receive rituximab, the humanized monoclonal antibody against the CD20 receptor on day 1 of each cycle.
A total of 348 patients will be enrolled on this protocol.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 348
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A EPOCH EPOCH + Rituximab every 3 weeks for 6 cycles. Arm A Rituximab EPOCH + Rituximab every 3 weeks for 6 cycles.
- Primary Outcome Measures
Name Time Method Overall response and PFS Time of progression The Dixon-Simon method will be used to determine whether large B-cell lymphomas expressing BCL-2 (+) patients may experience an improved progression free survival with EPOCH-R compared to EPOCH alone, and to obtain a concurrent, precisely determined measure of progression free survival.
- Secondary Outcome Measures
Name Time Method Safety and Toxicity Initiation of study drug until 30 days after treatment the proportion of patients with adverse events leading to discontinuation of therapy
Related Research Topics
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Trial Locations
- Locations (5)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States
Holy Cross Hospital, Fort Lauderdale
🇺🇸Fort Lauderdale, Florida, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Maryland, Baltimore
🇺🇸Baltimore, Maryland, United States
St. Luke's Roosevelt Hospital
🇺🇸New York, New York, United States