NCT04569032|CompletedPhase 2ResultsFDA Drug

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

A Dual-cohort, Open-label, Phase 2 Study of Brentuximab Vedotin and CHP (A+CHP) in the Frontline Treatment of Subjects With Peripheral T-cell Lymphoma (PTCL) With Less Than 10% CD30 Expression

Seagen, a wholly owned subsidiary of Pfizer ClinicalTrials.gov

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1 other identifier

SGN35-032

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredSep 2020

StartedNov 2020

CompletionJan 2026

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Nov 2020

Longer than P75 for phase_2

Geographic Reach

5 countries

63 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.2 years study duration

First Submitted

Initial submission to the registry

September 23, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed

1 month until next milestone

Study Start

First participant enrolled

November 12, 2020

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2024

Completed

1 year until next milestone

Results Posted

Study results publicly available

May 15, 2025

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2026

Completed

Last Updated

February 18, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

September 23, 2020

Results QC Date

April 28, 2025

Last Update Submit

January 29, 2026

Conditions

Peripheral T-cell Lymphoma

Keywords

CD30-positiveCD30-negativeSeattle Genetics

Outcome Measures

Primary Outcomes (1)

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) following the completion of study treatment (at end of treatment \[EOT\]). CR and PR per Cheson 2007: CR was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy and PR was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.
At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months

Secondary Outcomes (7)

Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment
At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
Progression Free Survival (PFS) Per BICR (Cheson 2007) by Central CD30 Assessment
From the first dose of study treatment to first documentation of objective tumor progression or death due to any cause or censoring, whichever came first (approximately 61.7 months)
Overall Survival (OS) by Central CD30 Assessment
From the first dose of study treatment until death or censoring date, whichever came first (approximately 61.7 months)
Duration of Response (DOR) Per BICR (Cheson 2007) by Central CD30 Assessment
From the first documented CR or PR until the first documentation of tumor progression, death or censoring date, whichever came first (up to 61.7 months)
ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment
At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
+2 more secondary outcomes

Study Arms (2)

CD30-negative Cohort

EXPERIMENTAL

Participants with CD30 expression level \< 1%

Drug: brentuximab vedotinDrug: cyclophosphamideDrug: doxorubicinDrug: prednisone

CD30-positive Cohort

EXPERIMENTAL

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

Drug: brentuximab vedotinDrug: cyclophosphamideDrug: doxorubicinDrug: prednisone

Interventions

brentuximab vedotinDRUG

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

Also known as: ADCETRIS

CD30-negative CohortCD30-positive Cohort

cyclophosphamideDRUG

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

CD30-negative CohortCD30-positive Cohort

doxorubicinDRUG

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

CD30-negative CohortCD30-positive Cohort

prednisoneDRUG

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

CD30-negative CohortCD30-positive Cohort

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Seagen, a wholly owned subsidiary of Pfizerlead

Study Sites (63)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Stanford Hospital and Clinics, Investigational Drug Services

Stanford, California, 94305, United States

Location