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
About this trial
This is an interventional treatment trial for Enteropathy Associated T-cell Lymphoma
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.
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
NCT ID
NCT03217643
First Posted
July 12, 2017
Last Updated
July 11, 2023
Sponsor
Imagine Institute
Collaborators
Takeda
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.
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