Brentuximab Vedotin in Combination With CHEP in Patient With PTCL

NCT05006664 | Unknown Phase 2

• 1 other identifier: CLSG-PTCL-CHEPA
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 7

Brief 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)

Conditions

Lymphoma, T-Cell, Peripheral

Keywords

CD30-expressing; brentuximab vedotin; CHEP

Outcome Measures

Primary Outcomes (1)

• PET-negative complete response (CR) rate at the end of treatment

  Complete response

  6m months

Secondary Outcomes (8)

• Type, incidence, severity, seriousness, and relatedness of treatment emergent adverse events.

  38 months

• Type, incidence, severity, seriousness, and relatedness of adverse events in the follow-up period.

  38 months

• Progression-free survival (PFS)

  12 months, 24 months

• Overall survival (OS)

  12months, 24 months,

• Event-free survival (EFS)

  12months, 24 months,

Study Arms (1)

Brentuximab Vedotin (Adcetris) in Combination with CHEP

EXPERIMENTAL

Single arm, open label, Brentuximab Vedotin (Adcetris) in Combination with CHEP

Drug: Adcetris 50 MG Injection; Drug: Endoxan; Drug: Doxorubicin; Drug: Etoposide; Drug: Prednisone tablet

Interventions

Adcetris 50 MG Injection DRUG

Treatment by study drug Brentuximab Vedotin (Adcetris) in combination with CHEP.

Also known as: Brentuximab Vedotin

Brentuximab Vedotin (Adcetris) in Combination with CHEP

Endoxan DRUG

Treatment by study drug Cyclophosphamide (Endoxan) in combination.

Also known as: Cyclophosphamide

Brentuximab Vedotin (Adcetris) in Combination with CHEP

Doxorubicin DRUG

Treatment by study drug Doxorubicin in combination.

Also known as: Doxorubicin Ebewe, Doxorubicin Medac

Brentuximab Vedotin (Adcetris) in Combination with CHEP

Etoposide DRUG

Treatment by study drug Etoposide in combination.

Also known as: Etoposide ACCORD

Brentuximab Vedotin (Adcetris) in Combination with CHEP

Prednisone tablet DRUG

Treatment by study drug Prednisone in combination.

Also known as: Prednison Léčiva

Brentuximab Vedotin (Adcetris) in Combination with CHEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Written informed consent
• 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:
• Systemic anaplastic large cell lymphoma (ALCL) ALK+ with age-adjusted international prognostic index (aaIPI) ≥1
• Systemic anaplastic large cell lymphoma (ALCL) ALK-
• Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
• Angioimmunoblastic T-cell lymphoma (AITL)
• Adult T-cell leukaemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukaemia 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
• Positive CD30 expression by local pathology assessment.

You may not qualify if:

• Current diagnosis of any following lymphomas:
• 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)
• Mycosis fungoides (MF), including transformed MF
• PTCL CD30-negative
• 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).
• Known central nervous system (CNS) lymphoma involvement
• Prior treatment with brentuximab vedotin.
• Baseline peripheral neuropathy ≥Grade 2 (per the NCI CTCAE, Version 5.0)
• 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.
• Any uncontrolled Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
• Known human immunodeficiency virus (HIV) infection, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
• History of hypersensitivity to any component of CHEP, to compounds of similar biological or chemical composition as brentuximab vedotin, and/or the excipients contained in any of the drug formulations of study treatment.
• Females who are pregnant or breastfeeding
• Planned CNS prophylaxis with intravenous high-dose methotrexate.

Sponsors & Collaborators

• Czech Lymphoma Study Group: lead

Study Sites (7)

University Hospital Brno

Brno, 625 00, Czechia

Location

University Hospital Hradec Králové

Hradec Králové, 500 05, Czechia

Location

University Hospital Olomouc

Olomouc, 775 20, Czechia

Location

University Hospital Ostrava

Ostrava, 70852, Czechia

Location

University Hospital Plzeň

Pilsen, 323 00, Czechia

Location

University Hospital Kralovske Vinohrady

Prague, 100 00, Czechia

Location

Charles University General Hospital

Prague, 128 08, Czechia

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Brentuximab Vedotin; Injections; Cyclophosphamide; Doxorubicin; Etoposide; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Magdaléna Zikmundová, MD, Ph.D.

  Subinvestigator, Protocol completation

  STUDY DIRECTOR

Central Study Contacts

Marek Trněný, prof. MD

CONTACT

+420 224 962 527; trneny@cesnet.cz

Veronika Nováková, Mgr.

CONTACT

+420 608 732 888; novakova@lymphoma.cz

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, single arm, combination - brentuximab vedotin+cyclophosphamide+doxorubicin+etoposide+prednison

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 16, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (7)