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NCT04569032

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

Last Updated: 2025-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-12

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral T-cell Lymphoma

Keywords

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CD30-positive CD30-negative Seattle Genetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CD30-negative Cohort

Participants with CD30 expression level \< 1%

Group Type EXPERIMENTAL

brentuximab vedotin

Intervention Type DRUG

1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

cyclophosphamide

Intervention Type DRUG

750 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

doxorubicin

Intervention Type DRUG

50 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

prednisone

Intervention Type DRUG

100 mg daily administered orally on Days 1-5 of each cycle

CD30-positive Cohort

Participants with CD30 expression level ≥1% to \< 10%

Group Type EXPERIMENTAL

brentuximab vedotin

Intervention Type DRUG

1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

cyclophosphamide

Intervention Type DRUG

750 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

doxorubicin

Intervention Type DRUG

50 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

prednisone

Intervention Type DRUG

100 mg daily administered orally on Days 1-5 of each cycle

Interventions

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brentuximab vedotin

1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

Intervention Type DRUG

cyclophosphamide

750 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

Intervention Type DRUG

doxorubicin

50 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

Intervention Type DRUG

prednisone

100 mg daily administered orally on Days 1-5 of each cycle

Intervention Type DRUG

Other Intervention Names

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ADCETRIS

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Stanford Cancer Center

Stanford, California, United States

Site Status

Stanford Hospital and Clinics, Investigational Drug Services

Stanford, California, United States

Site Status

Rocky Mountain Cancer centers, LLP

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer centers, LLP

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer centers, LLP

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Cancer centers, LLP

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer centers, LLP

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer centers, LLP

Lakewood, Colorado, United States

Site Status

Rocky Mountain Cancer centers, LLP

Littleton, Colorado, United States

Site Status

Rocky Mountain Cancer centers, LLP

Lone Tree, Colorado, United States

Site Status

Rocky Mountain Cancer centers, LLP

Longmont, Colorado, United States

Site Status

Rocky Mountain Cancer centers, LLP

Pueblo, Colorado, United States

Site Status

Rocky Mountain Cancer centers, LLP

Thornton, Colorado, United States

Site Status

Tulane Cancer Center

New Orleans, Louisiana, United States

Site Status

Tulane Medical Center

New Orleans, Louisiana, United States

Site Status

Memorial Sloan Kettering Cancer Center David H. Koch Center for Cancer Care

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Oncology_Hematology Care Clincal Trials,LLC

Cincinnati, Ohio, United States

Site Status

Oncology_Hematology Care Clincal Trials,LLC

Cincinnati, Ohio, United States

Site Status

Oncology_Hematology Care Clincal Trials,LLC

Cincinnati, Ohio, United States

Site Status

Oncology_Hematology Care Clincal Trials,LLC

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic taussig Cancer Center Investigational Pharmacy

Cleveland, Ohio, United States

Site Status

Cleveland Clinic, The

Cleveland, Ohio, United States

Site Status

Oncology_Hematology Care Clincal Trials,LLC

Fairfield, Ohio, United States

Site Status

Texas Oncology - Central/South Texas

Austin, Texas, United States

Site Status

Texas Oncology - Central South (Balcones Dr)

Austin, Texas, United States

Site Status

Texas Oncology - Central South (James Casey)

Austin, Texas, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

US Oncology Investigational Products Center (IPC)

Irving, Texas, United States

Site Status

US Oncology Investigational Products Center(IPC)

Irving, Texas, United States

Site Status

US Oncology lnvestigational Products Center (IPC)

Irving, Texas, United States

Site Status

Texas Oncology-Northeast Texas

Longview, Texas, United States

Site Status

Texas Oncology-Northeast Texas

Palestine, Texas, United States

Site Status

Texas Oncology-Northeast Texas

Paris, Texas, United States

Site Status

Texas Oncology-Northeast Texas

Tyler, Texas, United States

Site Status

Virginia Oncology Associates

Chesapeake, Virginia, United States

Site Status

Virginia Oncology Associates

Hampton, Virginia, United States

Site Status

Virginia Oncology Associates

Newport News, Virginia, United States

Site Status