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NCT Number: 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)

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lymphoproliferation Induced by HTLV-1 Deltaretrovirus Infections HTLV-1 Adult T-cell Lymphoma / Leukemia HTLV-1 Infection HTLV-I Infections Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Immunoproliferative Disorders Infections Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type RNA Virus Infections Retroviridae Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker Enfants Malades

Paris, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of survivors

    Time frame: Up to 1 year

    for cohorts 1 and 2

Secondary outcomes

  1. Number of survivors at 2 years

    Time frame: At 2 years

    for cohorts 1 and 2

  2. Number of survivors at 5 years

    Time frame: 5 years

    for cohorts 1 and 2

  3. HTLV-1 proviral load

    Time frame: day 1

    for cohorts 1 and 2

  4. viral integration profile

    Time frame: day 1

    for cohorts 1 and 2

  5. lymphocyte phenotyping of tumor cells

    Time frame: day 1

    for cohorts 1 and 2

  6. genetic analysis of tumor cells by Next-generation sequencing (NGS)

    Time frame: day 1

    for cohorts 1 and 2

  7. number of patients with HTLV-1-related hematological disorders

    Time frame: day 1

    for cohort 1

  8. number of patients with HTLV-1-related extra-hematological disorders

    Time frame: day 1

    for cohort 1

  9. types of ATL

    Time frame: day 1

    According the Shimoyama classification (smoldering, chronic, Acute and Lymphoma) for cohort 1

  10. 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

  11. Response to induction therapy

    Time frame: during 5 years

    according to established response criteria for ATL for cohort 1

  12. Progression free survival (PFS)

    Time frame: during 5 years

    for cohort 1

  13. relapse-related mortality

    Time frame: during 5 years

    for cohort 1

  14. chemotherapy-related mortality

    Time frame: during 5 years

    for cohort 1

  15. transplant-related mortality

    Time frame: during 5 years

    for cohort 1

  16. Number of serious adverse events according to WHO classification related to treatment received

    Time frame: during 5 years

    for cohort 1

  17. Allograft-specific characteristic

    Time frame: during 5 years

    (donor type, conditioning type, engraftment, graft-related mortality) for cohort 1

  18. number of progression to ATL

    Time frame: at 2 years

  19. Number of progression to ATL

    Time frame: At 5 years

  20. number of patients with HTLV-1-related extrahematological disorders

    Time frame: during 5 years

  21. 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

  22. Number of Serious adverse events according to WHO classification related to treatment received

    Time frame: during 5 years

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study 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

Acronym: HTLV-OBS

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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