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)

NCT05237245 | Active Not Recruiting

• 2 other identifiers: APHP1806842020-A02320-39
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Human T-lymphotropic Virus 1; lymphoma; leukemia

Outcome Measures

Primary Outcomes (1)

• Number of survivors

  for cohorts 1 and 2

  Up to 1 year

Secondary Outcomes (22)

• Number of survivors at 2 years

  At 2 years

• Number of survivors at 5 years

  5 years

• HTLV-1 proviral load

  day 1

• viral integration profile

  day 1

• lymphocyte phenotyping of tumor cells

  day 1

Study Arms (2)

1

Adult T-cell leukemia / lymphoma (ATL) patients

2

HTLV-1 chronically infected patients without ATL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- Patients refusal of participation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, affected organ biopsy

MeSH Terms

Conditions

Leukemia; HTLV-I Infections; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Deltaretrovirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• Ambroise MARCAIS, MD

  Assistance Publique-Hôpitaux Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 14, 2022
• Study Start: March 23, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)