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.

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. - EATL001

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002782-57-FR

Enrollment

Registered

2016-11-30

Start date

2016-11-22

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

enteropathy-associated T-cell lymphoma type 1

Interventions

Trade Name: Adcetris Product Name: Brentuximab Vedotin Pharmaceutical Form: Powder for solution for infusion Product Name: Cyclophosphamide Pharmaceutical Form: Powder for injection Product Name: Do

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

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. 6. Participation in any study of an investigational drug within 30 days prior to study entry...

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the 2-year progression-free survival (PFS).;Secondary Objective: - To evaluate the response rate - To evaluate the transplantation rate - To evaluate the overall survival (OS) - To evaluate the time to progression (TTP) - To evaluate the duration of response (DOR) - To evaluate the relapse rate - To evaluate the mobilization failure rate - To evaluate the safety and tolerability of BV-CHP - To evaluate the quality of life - To evaluate the nutritional status;Primary end point(s): 2-year progression-free survival (PFS);Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Main Objective: To evaluate the 2-year progression-free survival (PFS).;Secondary Objective: - To evaluate the response rate - To evaluate the transplantation rate - To evaluate the overall survival (OS) - To evaluate the time to progression (TTP) - To evaluate the duration of response (DOR) - To evaluate the relapse rate - To evaluate the mobilization failure rate - To evaluate the safety and tolerability of BV-CHP - To evaluate the quality of life - To evaluate the nutritional status;Primary end point(s): 2-year progression-free survival (PFS);Timepoint(s) of evaluation of this end point: 2 years

—

Secondary

Measure	Time frame
Secondary end point(s): - Efficacy - Objective response rate [ORR, Complete Response (CR) + Partial Response (PR)] according to the Lugano classification (after 4 cycles of BV-CHP, after 2 cycles of MTX and after HDT-ASCT) - Transplantation rate - Overall survival (OS) - Time to progression (TTP) - Duration of response (DOR) - Relapse rate - Mobilization failure Mobilization failure rate - Toxicity, safety Type, incidence, severity, seriousness and relatedness of adverse events Laboratory abnormalities - Quality of life QLQ-C30 questionnaire (cf. appendix 16.10) - Nutritional Status (cf. appendix 16.11) PG-SGA questionnaire Nutritional Risk Index (NRI) ;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Secondary end point(s): - Efficacy - Objective response rate [ORR, Complete Response (CR) + Partial Response (PR)] according to the Lugano classification (after 4 cycles of BV-CHP, after 2 cycles of MTX and after HDT-ASCT) - Transplantation rate - Overall survival (OS) - Time to progression (TTP) - Duration of response (DOR) - Relapse rate - Mobilization failure Mobilization failure rate - Toxicity, safety Type, incidence, severity, seriousness and relatedness of adverse events Laboratory abnormalities - Quality of life QLQ-C30 questionnaire (cf. appendix 16.10) - Nutritional Status (cf. appendix 16.11) PG-SGA questionnaire Nutritional Risk Index (NRI) ;Timepoint(s) of evaluation of this end point: 2 years

—

Countries

France

Contacts

Public ContactElisabeth Hulier-Ammar

Institut des maladies génétiques - Imagine

elisabeth.hulier-ammar@institutimagine.org

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026