Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripher… (NCT03113500) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
United States, Canada48 participantsStarted 2017-05-25
Plain-language summary
This phase II trial studies the side effects and how well brentuximab vedotin and combination chemotherapy work in treating patients with CD30-positive peripheral T-cell lymphoma. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, etoposide, and prednisone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin and combination chemotherapy may work better in treating patients with CD30-positive peripheral T-cell lymphoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Documented informed consent of participant and/or legally authorized representative
* Agreement to allow the use of archival tissue from diagnostic tumor biopsies will be retrieved and submitted post-enrollment
* If unavailable, exceptions may be granted with study principal investigator (PI) approval.
* Eastern Cooperative Oncology Group (ECOG) status =\< 2
* Histologically confirmed mature peripheral T-cell or natural killer (NK)-cell lymphoma per World Health Organization (WHO) classification, including:
* Anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) with international protein index (IPI) of 2 or higher (must have bulky \[defined as mass \>= 10 cm\] stage II, or stage III-IV disease)
* ALK-negative ALCL
* NOTE: Per amendment dated 05-10-19, ALCL will no longer be eligible except for Canada.
* PTCL-not otherwise specified (NOS)
* Angioimmunoblastic T-cell lymphoma (AITL)
* Adult T-cell lymphoma/leukemia (ATLL)
* Enteropathy-associated T-cell lymphoma (EATL)
* Hepatosplenic T-cell lymphoma
* CD30-positivity (e.g. at least 1%) by immunohistochemistry confirmed by hematopathology review at the participating institution
* Measurable disease of at least 1.5 cm on computed tomography (CT) or positron emission tomography (PET)-CT scan
* Absolute neutrophil count (ANC) \>= 1,000/mm\^3
* Exception: unless documented bone marrow involvement by lymphoma
* Platelets \>= 50,000/mm\^3
* Exception: unle…
What they're measuring
1
Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy