Clinical trial NCT05237245: 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)
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoproliferation Induced by HTLV-1
HTLV-1 Adult T-cell Lymphoma / Leukemia
HTLV-1 Infection
Keywords: Human T-lymphotropic Virus 1
lymphoma
leukemia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with lymphoproliferation induced by HTLV-1 (or HTLV-1 adult T-cell lymphoma / leukemia) and HTLV-1 infected patients

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of survivors
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of survivors at 2 years
timeFrame: At 2 years
measure: Number of survivors at 5 years
timeFrame: 5 years
measure: HTLV-1 proviral load
timeFrame: day 1
measure: viral integration profile
timeFrame: day 1
measure: lymphocyte phenotyping of tumor cells
timeFrame: day 1
measure: genetic analysis of tumor cells by Next-generation sequencing (NGS)
timeFrame: day 1
measure: number of patients with HTLV-1-related hematological disorders
timeFrame: day 1
measure: number of patients with HTLV-1-related extra-hematological disorders
timeFrame: day 1
measure: types of ATL
timeFrame: day 1
measure: Treatment lines
timeFrame: during 5 years
measure: Response to induction therapy
timeFrame: during 5 years
measure: Progression free survival (PFS)
timeFrame: during 5 years
measure: relapse-related mortality
timeFrame: during 5 years
measure: chemotherapy-related mortality
timeFrame: during 5 years
measure: transplant-related mortality
timeFrame: during 5 years
measure: Number of serious adverse events according to WHO classification related to treatment received
timeFrame: during 5 years
measure: Allograft-specific characteristic
timeFrame: during 5 years
measure: number of progression to ATL
timeFrame: at 2 years
measure: Number of progression to ATL
timeFrame: At 5 years
measure: number of patients with HTLV-1-related extrahematological disorders
timeFrame: during 5 years
measure: Number of patients with corticotherapy for extrahematological complications
timeFrame: during 5 years
measure: Number of Serious adverse events according to WHO classification related to treatment received
timeFrame: during 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
Study officials:
affiliation: Assistance Publique-Hôpitaux Paris
name: Ambroise MARCAIS, MD
role: PRINCIPAL_INVESTIGATOR
References: