Enrollment Temporarily Closed
This study is temporarily closed to new enrollments. Please contact the study team for more information or check back frequently.

Alliance A051701 (Lymphoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see how an experimental drug called venetoclax works in your body and against your cancer. We want to know if the addition of this drug to standard chemotherapy can improve treatment for people with double-hit or double expressing lymphoma. These lymphoma types are aggressive (fast-growing) B-cell lymphomas.

What is the Condition Being Studied?

MYC/BCL2 Double-Hit and Double Expressing Lymphomas

Who Can Participate in the Study?

Adults who have double-hit or double expressing lymphoma.

Age Group
Adults

What is Involved?

If you choose to join the study, you will:
- Be randomly assigned (like the flip of a coin) to 1 of 2 groups
-- One group will receive standard chemotherapy (R-CHOP or EPOCH-R) for up to 18 weeks
-- The other group will receive standard chemotherapy plus the study drug venetoclax for up to 18 weeks

R-CHOP chemotherapy uses the following drugs:
- Rituximab (R)
- Cyclophosphamide (C)
- Doxorubicin (H)
- Vincristine (O)
- Prednisone (P)

EPOCH-R chemotherapy uses the following drugs:
- Etoposide (E)
- Prednisone (P)
- Vincristine (O)
- Cyclophosphamide (C)
- Doxorubicin (H)
- Rituximab (R)

When your treatment is finished, you will:
- Have follow-up visits every 3 months for the first 2 years after treatment
- Have follow-up visits every 6 months for the 3rd, 4th, and 5th years after treatment
- Have follow-up phone calls or visits every 6 months for another 5 years once it has been 5 years after treatment

Study Details

Full Title
Alliance A051701: Randomized Phase II/III Study of Venetoclax (ABT 199) plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00104524
NCT: NCT03984448
Phase
Phase II/III
ClinicalTrials.gov
Enrollment Status
Enrollment Temporarily Closed
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698