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)

Recruiting

• Conditions: HTLV-1 Infection; Lymphoproliferation Induced by HTLV-1; HTLV-1 Adult T-cell Lymphoma / Leukemia

• Registration Number: NCT05237245
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-14
• Study Start: 2022-03-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of survivors	Up to 1 year	for cohorts 1 and 2

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Necker Enfants Malades; 🇫🇷 Paris, France