CHP-BV Followed by Consolidation With High-dose Therapy / ASCT as Frontline Treatment of Patients With EATL Type 1.

NCT03217643 | Completed Phase 2 DMC

• 1 other identifier: IMIS2015-03
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

It has been recently reported that EATL type 1, but not refractory coeliac disease, strongly expressed CD30 and might benefit from brentuximab vedotin. Since the safety profile of the combination brentuximab vedotin and CHP is known and since the role of etoposide as part of induction regimen is not demonstrated, the investigator will assess the efficacy and toxicity of the combination brentuximab vedotin and CHP followed by HDT/ASCT, as frontline treatment of EATL.

Conditions

Enteropathy Associated T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Evaluate the 2-year progression-free survival

  2-year progression-free survival (PFS)

  4 years

Study Arms (1)

Brentuximab Vedotin

EXPERIMENTAL

The first part of the treatment (induction) will evaluate BV-CHP. The second part of the treatment (consolidation) will use standard drugs for the treatment of lymphoma. HDT will consist of BEAM conditioning regimen (or BAM if carmustine is not available). Management of HDT/ASCT will be done according to standard practice.

Drug: Brentuximab Vedotin

Interventions

Brentuximab Vedotin DRUG

The first part of the treatment (induction) will evaluate BV-CHP. The second part of the treatment (consolidation) will use standard drugs for the treatment of lymphoma. HDT will consist of BEAM conditioning regimen (or BAM if carmustine is not available). Management of HDT/ASCT will be done according to standard practice.

Brentuximab Vedotin

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of EATL based on criteria established by the World Health Organization (WHO) 2016 Classification of Tumors of Haematopoietic and Lymphoid Tissues.
• EATL should be CD30-positive with a threshold of 10%.
• Patients aged ≥ 18 years and \< 70 years at the time of study entry.
• ECOG performance status 0 to 3 at time of study entry.
• Left Ventricular Ejection Fraction (LVEF) ≥ 45% measured by bidimensional echography or radionuclide ventriculography (MUGA scan).

You may not qualify if:

• Participants must not have been treated with any prior chemotherapy for EATL. Patients with previous treatment for refractory celiac disease (i.e., immunosuppressive or immunoregulatory drugs) may be included.
• Known central nervous system involvement by EATL.
• Active chronic hepatitis B or C.
• HIV positive serology.
• HTLV-1 positive serology.

Sponsors & Collaborators

• Imagine Institute: lead
• Takeda: collaborator

Study Sites (1)

Hopital Necker - Enfants malades

Paris, France

Location

MeSH Terms

Conditions

Enteropathy-Associated T-Cell Lymphoma

Interventions

Brentuximab Vedotin

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

Study Officials

• Hermine Olivier

  Hôpital Necker-Enfants Malades

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 14, 2017
• Study Start: February 7, 2018
• Primary Completion: November 21, 2022
• Study Completion: May 15, 2023
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)