Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Adults and Children With Previously Untreated Patients With Aggressive Non-Hodgkin's Lymphoma|
- Complete response after completion of study treatment [ Designated as safety issue: No ]
- Progression-free survival 5 years after completion of study treatment [ Designated as safety issue: No ]
- Toxicity during treatment [ Designated as safety issue: Yes ]
- Patterns of mdr-1. bcl-2, MIB-1, and mutant p53 expression in untreated lymphomas at completion of study treatment [ Designated as safety issue: No ]
|Study Start Date:||April 1993|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Combination chemotherapy--EPOCH-R given IV over 5 days every 3 weeks for 6 cycles.
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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.
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.
Assess PFS in bcl-2 + lymphomas treated with dose-adjusted EPOCH-R, and determine if it is significantly better than dose-adjusted EPOCH alone.
Obtain pilot information on the CR and PFS of dose-adjusted EPOCH with G-CSF in CD20 negative B cell lymphomas, anaplastic large cell lymphomas (ALCL) and peripheral T-cell lymphomas (PTCL).
Assess toxicity of dose-adjusted EPOCH-Rituximab with G-CSF in agressive lymphomas.
Characterize the patterns of mdr-1, bcl-2, MIB-1 and mutant p53 expression in previously untreated lymphoma patients.
Assess the effect of EPOCH-R on ovarian function and reserve in female patients with PMBL.
Non-Hodgkin's lymphomas in the following categories: diffuse large B-cell to include
gray zone lymphoma and follicular center cell grade IIIB, anaplastic large cell, aggressive
T-cell lymphomas and Burkitt Lymphoma.
Patients greater than or equal to 12 years old.
Stages II, III, IV for all subtypes, and Stage I for bulky (> 5 cm) primary mediastinal
lymphomas or Burkitt Lymphoma.
No prior systemic chemotherapy.
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 318 patients will be enrolled on this protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001337
|Contact: Margaret Shovlin, R.N.||(301) firstname.lastname@example.org|
|Contact: Wyndham H Wilson, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Wyndham H Wilson, M.D.||National Cancer Institute (NCI)|