A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression

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

  • Peripheral T-cell Lymphoma

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