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-OBS)

March 24, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Necker Enfants Malades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Adult T-cell leukemia / lymphoma (ATL) patients
2
HTLV-1 chronically infected patients without ATL

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Ambroise MARCAIS, MD, Assistance Publique-Hôpitaux Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP180684
  • 2020-A02320-39 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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