Clinico-biological Characterization and Survival of Patients With Adult T-cell Leukemia / Lymphoma (ATL) and Patients Chronically Infected With the HTLV-1 Virus (HTLV-OBS)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the outcome (survival) of Adult T-cell leukemia / lymphoma (ATL) patients who receive or not specific treatment for their hemopathy (cohort 1) and the outcome (survival) of HTLV-1 chronically infected patients with / without extra-haematological disorders (cohort 2).

Official Title
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Caractérisation Clinico- Biologique et Survie Des Patients Porteurs d'Une lymphoprolifération HTLV-1 Induite (ou Lymphome/leucémie lié au Virus HTLV-1) et Des Patients infectés Par le Virus HTLV-1

Conditions
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Lymphoproliferation Induced by HTLV-1, HTLV-1 Adult T-cell Lymphoma / Leukemia, HTLV-1 Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older HTLV-1 infected T lymphoproliferation induced by HTLV-1 (cohort 1) without T lymphoproliferation induced by HTLV-1 (cohort 2) informed and accepted the collection of data Exclusion Criteria - Patients refusal of participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Adult T-cell leukemia / lymphoma (ATL) patients | |
| 2<br>HTLV-1 chronically infected patients without ATL | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of survivors | for cohorts 1 and 2 | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of survivors at 2 years | for cohorts 1 and 2 | At 2 years | 
| Number of survivors at 5 years | for cohorts 1 and 2 | 5 years | 
| HTLV-1 proviral load | for cohorts 1 and 2 | day 1 | 
| viral integration profile | for cohorts 1 and 2 | day 1 | 
| lymphocyte phenotyping of tumor cells | for cohorts 1 and 2 | day 1 | 
| genetic analysis of tumor cells by Next-generation sequencing (NGS) | for cohorts 1 and 2 | day 1 | 
| number of patients with HTLV-1-related hematological disorders | for cohort 1 | day 1 | 
| number of patients with HTLV-1-related extra-hematological disorders | for cohort 1 | day 1 | 
| types of ATL | According the Shimoyama classification (smoldering, chronic, Acute and Lymphoma) for cohort 1 | day 1 | 
| Treatment lines | Chemotherapy type, number of Chemotherapy cycles, efficacity of Chemotherapy : Number of complete remissions following treatment : for cohort 1 | during 5 years | 
| Response to induction therapy | according to established response criteria for ATL for cohort 1 | during 5 years | 
| Progression free survival (PFS) | for cohort 1 | during 5 years | 
| relapse-related mortality | for cohort 1 | during 5 years | 
| chemotherapy-related mortality | for cohort 1 | during 5 years | 
| transplant-related mortality | for cohort 1 | during 5 years | 
| Number of serious adverse events according to WHO classification related to treatment received | for cohort 1 | during 5 years | 
| Allograft-specific characteristic | (donor type, conditioning type, engraftment, graft-related mortality) for cohort 1 | during 5 years | 
| number of progression to ATL |  | at 2 years | 
| Number of progression to ATL |  | At 5 years | 
| number of patients with HTLV-1-related extrahematological disorders |  | during 5 years | 
| Number of patients with corticotherapy for extrahematological complications | Dose of corticotherapy for extrahematological complications, number of days with corticotherapy for extrahematological complications | during 5 years | 
| Number of Serious adverse events according to WHO classification related to treatment received |  | during 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human T-lymphotropic Virus 1, lymphoma, leukemia