Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma

This study is currently recruiting participants.
Verified September 2011 by National Institutes of Health Clinical Center (CC)

First Received on March 23, 2010.  
Last Updated on June 28, 2012  
History of Changes
This Clinical Trial Sponsored By: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01092182
 

Purpose for Clinical Trial

Background:

  • Burkitt lymphoma/leukemia (BL) is highly treatable, but most of the standard therapies require multiple doses of intensive chemotherapy that may require long hospital stays and frequently have severe side effects. In addition, BL is a fairly common type of cancer in patients who also have human immunodeficiency virus (HIV), but treatment outcomes are poor because standard treatments do not work very well in HIV-positive patients and the more intense treatment regimens are highly toxic. New approaches are needed that expand the ways to treat BL with the same efficiency but with reduced side effects.
  • DA-EPOCH-R is a standard chemotherapy treatment that consists of the drugs etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. It may be able to treat BL with similar effectiveness but with fewer side effects. Researchers are interested in confirming the results of previous studies that investigated the effectiveness of DA-EPOCH-R in treating BL.

Objectives:

– To determine the safety and effectiveness of DA-EPOCH-R in treating Burkitt lymphoma.

Eligibility:

– Individuals at least 18 years of age who have been diagnosed with Burkitt lymphoma and have not had any prior chemotherapy treatments.

Design:

  • Individuals will have a series of blood and other tests to determine their suitability for participating in the study. Eligible participants will be divided into high-risk and low-risk groups based on their disease prognosis and the possibility that the BL may or already has spread into the central nervous system.
  • Participants will receive intravenous infusion of the six chemotherapy drugs in DA-EPOCH-R in 21-day treatment cycles. The exact doses will be adjusted depending on participants’ white blood cell counts and other tests.
  • High-risk participants will receive six cycles of DA-EPOCH-R. To treat BL that may have entered the central nervous system, high-risk participants will also receive infusions of other chemotherapy drugs into their spinal fluid.
  • Low-risk participants will receive up to six cycles of DA-EPOCH-R, with an additional dose of rituximab during each cycle.
  • Frequent blood and urine tests will be performed during treatment, as well as body imaging scans and other tests of cancer progression as directed by the study doctors. Participants will receive additional medicines to help prevent possible adverse side effects of DA-EPOCH-R.
  • Participants who respond successfully to the treatment will be asked to return for follow-up exams every 3 months for the first 18 months, then every year for the next 3 years. Participants who do not respond successfully to the treatment will be given the opportunity to participate in additional research and treatment protocols, if any are available.

Condition Study Intervention Phase
Burkitt Lymphoma
Diffuse Large B-cell Lymphoma, c-MYC Positive
Drug: rituximab
Drug: etoposide
Drug: cyclophosphamide
Drug: doxorubicin
Drug: vincristine
Drug: prednisone
Drug: filgrastim
Phase 2

Study Type: Study Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Study Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Dose-Adjusted EPOCH+/-Rituximab in Adults With Untreated Burkitt Lymphoma, c-MYC Positive Diffuse Large B-Cell Lymphoma and Plasmablastic Lymphoma

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
HIV/AIDS
Lymphoma
Drug Information available for:
Cyclophosphamide
Prednisone
Vincristine sulfate
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Rituximab

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures For Clinical Trial:

  • Determine PFS, EFS and OS of risk adaptive DA-EPOCH-R in newly diagnosed Burkitt Lymphoma and c-MYC + DLBCL and DA-EPOCH in c-MYC+ plasmablastic lymphoma. [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Assess predictive value of early FDG-PET scans on PFS. Obtain pilot comparative molecular profiling in HIV negative and positive BL and c-MYC + DLBCL, including c-MYC+ plasmablastic lymphoma. [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 153
Study Start Date: February 2010
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

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