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)

HTLV-1 Infection Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05237245
• Other study ID #: APHP180684
• Secondary ID: 2020-A02320-39
• Status: Recruiting
• Start date: March 23, 2022
• Est. completion date: March 2027

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Ambroise MARCAIS, MD
• Phone: +33 1 44 49 46 99
• Email: ambroise.marcais[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HTLV-1 Infection
• HTLV-I Infections
• Leukemia
• Leukemia-Lymphoma, Adult T-Cell
• Lymphoma

Locations

Country	Name	City	State
France	Hôpital Necker Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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