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Purpose

This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Newly diagnosed PTCL, excluding systemic anaplastic large cell lymphoma (sALCL), per the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification - The following non-sALCL PTCL subtypes are eligible: - PTCL - not otherwise specified (PTCL-NOS) - Angioimmunoblastic T-cell lymphoma (AITL) - Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1) - Enteropathy-associated T-cell lymphoma (EATL) - Hepatosplenic T-cell lymphoma - Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL) - Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract - Follicular T-cell lymphoma - Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype - CD30 expression <10% by local assessment in tumor containing lymph node or other extranodal soft tissue biopsy - Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist - An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion Criteria

  • Current diagnosis of any of the following: - sALCL - Primary cutaneous T-cell lymphoproliferative disorders and lymphomas - Mycosis fungoides (MF), including transformed MF - History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. - History of progressive multifocal leukoencephalopathy (PML). - Cerebral/meningeal disease related to the underlying malignancy. - Prior treatment with brentuximab vedotin or doxorubicin. - Baseline peripheral neuropathy Grade 2 or higher (per the NCI CTCAE, Version 4.03) or subjects with the demyelinating form of Charcot-Marie-Tooth syndrome. - Left ventricular ejection fraction less than 45% or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), or myocardial infarction within the past 6 months, or previous treatment with complete cumulative dose of >300 mg/m2 of doxorubicin. - Any uncontrolled Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CD30-negative Cohort 		Participants with CD30 expression level < 1%
  • Drug: brentuximab vedotin
    1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
    Other names:
    • ADCETRIS
  • Drug: cyclophosphamide
    750 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
  • Drug: doxorubicin
    50 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
  • Drug: prednisone
    100 mg daily administered orally on Days 1-5 of each cycle
Experimental
CD30-positive Cohort 		Participants with CD30 expression level ≥1% to < 10%
  • Drug: brentuximab vedotin
    1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
    Other names:
    • ADCETRIS
  • Drug: cyclophosphamide
    750 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
  • Drug: doxorubicin
    50 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
  • Drug: prednisone
    100 mg daily administered orally on Days 1-5 of each cycle

More Details

Status
Active, not recruiting
Sponsor
Seagen Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.