Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01092182|
Recruitment Status : Active, not recruiting
First Posted : March 24, 2010
Last Update Posted : September 28, 2020
- 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.
- To determine the safety and effectiveness of DA-EPOCH-R in treating Burkitt lymphoma.
- Individuals at least 18 years of age who have been diagnosed with Burkitt lymphoma and have not had any prior chemotherapy treatments.
- 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 or disease||Intervention/treatment||Phase|
|Burkitt Lymphoma Diffuse Large B-cell Lymphoma, c-MYC Positive Plasmablastic Lymphoma||Drug: EPOCH-R Drug: EPOCH-RR||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 25, 2010|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||February 28, 2023|
Burkitt lymphoma Low Risk Arm
EPOCH-R every 21 days for 3 cycles
Burkitt lymphoma High Risk Arm
EPOCH-R every 21 days for 6 cycles
DLBCL high risk arm
EPOCH-R every 21 days for 6 cycles
- PFS, EFS and OS [ Time Frame: Time of progression or death ]Kaplan-Meier curves will be constructed, with 80% and 95% confidence intervals determined at 1, 2, and 3 years
- PFS [ Time Frame: after cycle 2 and cycle 6 (if applicable) ]Assess predictive value of early FDG-PET/CT scans on PFS
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): NCT01092182
|Principal Investigator:||Mark J Roschewski, M.D.||National Cancer Institute (NCI)|