BV-CHEP Chemotherapy for Adult T-cell Leukemia or Lymphoma
Status:
Recruiting
Trial end date:
2028-12-15
Target enrollment:
Participant gender:
Summary
Adult T-cell leukemia/lymphoma (ATLL) is a rare form of cancer found mostly among people from
the Caribbean islands, Western Africa, Brazil, Iran, and Japan. Most cases of this disease in
the United States occur along the East Coast due to emigration from the Caribbean islands.
There is currently no standard treatment for ATLL. Research shows that patients who go into
first time remission (respond completely or partially to treatment) and have a bone marrow
transplant have the best outcomes. Traditional chemotherapy treatments have generally not
worked well in patients with ATLL. Additionally, not all patients will be eligible for a bone
marrow transplant.
The purpose of this study is to see how well individuals with ATLL respond to an
investigational cancer treatment. This investigational treatment combines a drug called
brentuximab vedotin with a standard chemotherapy treatment made up of cyclophosphamide,
doxorubicin, etoposide, and prednisone. This treatment is considered investigational because
it is not approved by the United States Food and Drug Administration (FDA) for the treatment
of ATLL.
Brentuximab vedotin, also known as Adcetris, is approved by the United States Food and Drug
Administration (FDA) for treatment of certain types of lymphomas, including peripheral T-cell
lymphomas when combined with cyclophosphamide, doxorubicin, and prednisone in patients whose
cancer cells express a type of marker called CD30.
Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it.
Antibodies are proteins that are part of the immune system. They can stick to and attack
specific targets on cancer cells. The antibody part of brentuximab vedotin sticks to a target
called cluster of differentiation 30 (CD30) that is located on the outside of the cancer
cells. Normal cells have little or no CD30 on their surface. ATLL cancer cells often have a
larger amount of CD30 on their surface than normal cells. However, CD30 is found in different
amounts on ATLL cancer cells. This study will also test the amount of CD30 found on each
participant's cancer cells. Researchers will be looking to see if the response to the study
treatment varies based on the amount of CD30 found on the outside participants' cancer cells.
In another study, brentuximab vedotin was combined in another study with cyclophosphamide,
doxorubicin, and prednisone. The study included patients with various types of T-cell
lymphomas. Two of the patients enrolled in that study had ATLL. Both had a complete response
(no evidence of disease). The researchers in this study (LCCC 1637) have added etoposide to
the combination of brentuximab vedotin with cyclophosphamide, doxorubicin, and prednisone.
They predict that the addition of etoposide will improve patient outcomes. Research shows
that etoposide helps improve outcomes in patients with certain types of T-cell lymphomas who
undergo chemotherapy treatment. This investigational combination of brentuximab vedotin with
cyclophosphamide, doxorubicin, etoposide, and prednisone is called BV-CHEP.