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.
- Conditions
- enteropathy-associated T-cell lymphoma type 1Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2016-002782-57-FR
- Lead Sponsor
- Institut des maladies génétiques - Imagine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 25
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...
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
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...
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method