High Risk Adult T-cell Leukemia/Lymphoma (ATLL-HR) and Allogeneic Transplant (ATLL-HR-01)

University Hospital Center of Martinique

Status: Completed

Conditions: T-cell Lymphoma; Leukaemia

Study type: Observational

Funder types: Other

Identifiers

NCT01941680

13/B/04

2013-A00327-38 (Other Identifier)

Details and patient eligibility

About

Patients are recruited at diagnosis or at relapse of ATLL-HR in French Caribbean islands and Guyana. They all receive Zidovudine and Pegylated Interferon (ZPI). For patients younger than 65 years old, an allogeneic donor is searching out. Patients included at relapse and with lymphoma clinico-biological subtype also receive chemotherapy (CT). Responses are assessed during ZPI+/-CT and eligible patients (depending on age, comorbidities and response criteria) receive allogeneic transplant. Patient follow-up is planned for 3 years old

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient >18 years old and ≤ 75 years old, with ATLL-HR who signed informed consent.

Exclusion criteria

• Pregnant or nursing women are not eligible; neither are women of childbearing potential unless using effective contraception as determined by the patient's physician.

Trial design

20 participants in 3 patient groups

ZPI

Description:

Zidovudine 1000mg/day : Retrovir® 250mg/day) PegINF (Pegasys®) 180μg x1 injection/week

ZPI+CHOP-21

Description:

Zidovudine 1000mg/day : Retrovir® 250mg/day) PegINF (Pegasys®) 180μg x1 injection/week CHOP-21 Day1 = day 21 (3 cycles) Day 1 Cyclophosphamide : 750 mg/m2, Doxorubicine : 50 mg/m2, Vincristine : 1,4mg/m2, Prednisone : 100mg/day PO. day 2-Day 5 Prednisone 1mg/kg/day PO.

ZPI +DHAP-21

Description:

Zidovudine 1000mg/day : Retrovir® 250mg/day) PegINF (Pegasys®) 180μg x1 injection/week DHAP Day 1= day 21 (3 cycles) Day 1 : Cisplatina 100 mg/m2 Day 2 and day 3 : Aracytine 2000mg/m2/day Day 1-day 4 : Dexamethasone 40mg