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Brentuximab Vedotin in Combination With CHEP in Patient With PTCL | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Brentuximab Vedotin in Combination With CHEP in Patient With PTCL

A Phase II Open Label Study of Brentuximab Vedotin in Combination With CHEP in Patients With Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL)

NCT05006664•Czech Lymphoma Study Group

View on ClinicalTrials.gov

Summary

A Phase II Open Label Study of Brentuximab Vedotin in Combination with CHEP in Patients with Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL)

Detailed Description

Efficacy assessments will be made according to the revised response criteria for malignant lymphoma based on the guidelines of the Lugano Classification (as reported by Cheson B et al. 2014) and will be based on investigator assessment Efficacy will be evaluated in terms of CR rate, ORR, PFS, EFS, OS. The safety and tolerability of study treatment will be evaluated by means of AE reports (nature, severity, frequency, causality), performance status, physical examinations, ECG and laboratory safety evaluations.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age \>18 years
•2. Written informed consent
•3. Histologically confirmed diagnosis of CD30-expressing PTCL. The following histological subtypes according to the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification are eligible:
•1. Systemic anaplastic large cell lymphoma (ALCL) ALK+ with age-adjusted international prognostic index (aaIPI) ≥1
•2. Systemic anaplastic large cell lymphoma (ALCL) ALK-
•3. Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
•4. Angioimmunoblastic T-cell lymphoma (AITL)
•5. Adult T-cell leukaemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukaemia virus 1)
•6. Enteropathy-associated T-cell lymphoma (EATL)
•7. Hepatosplenic T-cell lymphoma
+20 more criteria

Exclusion Criteria

•1. Current diagnosis of any following lymphomas:
•1. Primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas. Cutaneous ALCL with extracutaneous tumour spread beyond locoregional lymph nodes is eligible (previous single-agent treatment to address cutaneous and locoregional disease is permissible)
•2. Mycosis fungoides (MF), including transformed MF
•3. PTCL CD30-negative
•2. 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.
•3. History of progressive multifocal leukoencephalopathy (PML).
•4. Known central nervous system (CNS) lymphoma involvement
•5. Prior treatment with brentuximab vedotin.
•6. Baseline peripheral neuropathy ≥Grade 2 (per the NCI CTCAE, Version 5.0)
•7. Left ventricular ejection fraction (LVEF) of \< 45% or history of myocardial infarction ≤6 months, or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias) or prior treatment with anthracyclines.
+5 more criteria

Locations (7)

University Hospital Brno

Brno, Czechia

University Hospital Hradec Králové

Hradec Králové, Czechia

University Hospital Olomouc

Olomouc, Czechia

University Hospital Ostrava

Ostrava, Czechia

University Hospital Plzeň

Pilsen, Czechia

University Hospital Kralovske Vinohrady

Prague, Czechia

Charles University General Hospital

Prague, Czechia

Key Dates

Start Date

October 1, 2021

Primary Completion Date

October 1, 2024

Completion Date

October 1, 2024

Last Updated

September 1, 2021

Enrollment

ESTIMATED participants

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Adcetris 50 MG Injection

DRUG

Endoxan

DRUG

Doxorubicin

DRUG

Etoposide

DRUG

Prednisone tablet

DRUG

Contacts

Marek Trněný, prof. MD

CONTACT

+420 224 962 527 trneny@cesnet.cz

Veronika Nováková, Mgr.

CONTACT

+420 608 732 888 novakova@lymphoma.cz

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

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Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedAngioimmunoblastic T-cell Lymphoma+5 more

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RECRUITINGPHASE3

Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Brentuximab Vedotin in Combination With CHEP in Patient With PTCL

Inclusion Criteria

Exclusion Criteria

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype

T Cells Expressing a Fully-Human Anti-CD30 Chimeric Antigen Receptor for Treating CD30-Expressing Lymphomas

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma