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

N/ACompletedNCT01941680

University Hospital Center of Martinique20 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

T-cell Lymphoma Leukaemia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (2)

CHU Pinteà Pitre/Abymes

Pointe-à-Pitre, Guadeloupe

CHU de Martinique

Fort-de-France, Martinique

Outcomes

Primary Outcomes

Number of patients with relapse

Time frame: Up to 3 year

Secondary Outcomes

Evidence of presence of gene expression of Tax and HBZ confirmed by Rt-PCR

The titrations of genes are performed at month 12, month 24 and month 36

Time frame: 1 year

Data from ClinicalTrials.gov

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