Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00001337|
Recruitment Status : Active, not recruiting
First Posted : November 4, 1999
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-Cell Lymphoma (DLBCL) Primary Mediastinal Large B-cell Lymphoma Burkitt Lymphoma Anaplastic Large-Cell Lymphoma Gray Zone Lymphoma||Drug: EPOCH Biological: Rituximab||Phase 2|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||348 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Adults and Children With Previously Untreated Patients With Aggressive Non-Hodgkin's Lymphoma|
|Actual Study Start Date :||May 8, 1993|
|Estimated Primary Completion Date :||June 30, 2025|
|Estimated Study Completion Date :||June 30, 2025|
Experimental: Arm A
EPOCH + Rituximab every 3 weeks for 6 cycles.
Combination chemotherapy given with Rituximab (EPOCH-R) IV every 3 weeks for 6 cycles.
Rituximab given on Day 1 of combination chemotherapy (EPOCH-R) every 3 weeks for 6 cycles.
- Overall response and PFS [ Time Frame: 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.
- Safety and Toxicity [ Time Frame: Initiation of study drug until 30 days after treatment ]the proportion of patients with adverse events leading to discontinuation of therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001337
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Mark J Roschewski, M.D.||National Cancer Institute (NCI)|