search
Back to results

CHP-BV Followed by Consolidation With High-dose Therapy / ASCT as Frontline Treatment of Patients With EATL Type 1. (EATL-001)

Primary Purpose

Enteropathy Associated T-cell Lymphoma

Status
Active
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Brentuximab Vedotin
Sponsored by
Imagine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Enteropathy Associated T-cell Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

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

Main Exclusion Criteria:

  1. 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.
  2. Known central nervous system involvement by EATL.
  3. Active chronic hepatitis B or C.
  4. HIV positive serology.
  5. HTLV-1 positive serology.

Sites / Locations

  • Hopital Necker - Enfants malades

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brentuximab Vedotin

Arm Description

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.

Outcomes

Primary Outcome Measures

Evaluate the 2-year progression-free survival
2-year progression-free survival (PFS)

Secondary Outcome Measures

Full Information

First Posted
July 12, 2017
Last Updated
July 11, 2023
Sponsor
Imagine Institute
Collaborators
Takeda
search

1. Study Identification

Unique Protocol Identification Number
NCT03217643
Brief Title
CHP-BV Followed by Consolidation With High-dose Therapy / ASCT as Frontline Treatment of Patients With EATL Type 1.
Acronym
EATL-001
Official Title
Phase 2 Study of Brentuximab Vedotin Associated With CHP Followed by Consolidation With High-dose Therapy / Autologous Stem-cell Transplantation as Frontline Treatment of Patients With Enteropathy-associated T-cell Lymphoma Type 1.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
February 6, 2024 (Anticipated)
Study Completion Date
February 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imagine Institute
Collaborators
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Brentuximab vedotin is an anti-CD30 monoclonal antibody conjugated to the cytotoxic drug monomethyl auristatin E. It is currently evaluated in combination with multi-agent chemotherapy as frontline treatment of systemic ALCL (sALCL) and other CD30-positive mature T cell and NK cell lymphomas. Preliminary results of this phase 1 study have been presented at the 2012 ASH Annual Meeting: 26 patients have been treated with combination brentuximab vedotin and CHP. Nineteen of 26 patients had a diagnosis of sALCL and 7 patients had a diagnosis of another mature Tor NK-cell lymphoma (EATL, n=1). The maximum tolerated dose of brentuximab vedotin in combination with CHP was not exceeded at 1.8 mg/kg IV. Adverse events were manageable. All patients achieved an objective response, with 23 patients (88%) achieving a complete response (CR). All 7 non-sALCL patients achieved a CR. Finally, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteropathy Associated T-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brentuximab Vedotin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Brentuximab Vedotin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the 2-year progression-free survival
Description
2-year progression-free survival (PFS)
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: 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). Main Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hermine Olivier
Organizational Affiliation
Hôpital Necker-Enfants Malades
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Necker - Enfants malades
City
Paris
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs