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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)

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05237245
Collaborator
(none)
120
Enrollment
60
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Anticipated Study Start Date :
    Feb 1, 2022
    Anticipated Primary Completion Date :
    Feb 1, 2027
    Anticipated Study Completion Date :
    Feb 1, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Adult T-cell leukemia / lymphoma (ATL) patients
    2

    HTLV-1 chronically infected patients without ATL

    Outcome Measures

    Primary Outcome Measures

    1. Number of survivors [Up to 1 year]

      for cohorts 1 and 2

    Secondary Outcome Measures

    1. Number of survivors at 2 years [At 2 years]

      for cohorts 1 and 2

    2. Number of survivors at 5 years [5 years]

      for cohorts 1 and 2

    3. HTLV-1 proviral load [day 1]

      for cohorts 1 and 2

    4. viral integration profile [day 1]

      for cohorts 1 and 2

    5. lymphocyte phenotyping of tumor cells [day 1]

      for cohorts 1 and 2

    6. genetic analysis of tumor cells by Next-generation sequencing (NGS) [day 1]

      for cohorts 1 and 2

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

      for cohort 1

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

      for cohort 1

    9. types of ATL [day 1]

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

    10. Treatment lines [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 [during 5 years]

      according to established response criteria for ATL for cohort 1

    12. Progression free survival (PFS) [during 5 years]

      for cohort 1

    13. relapse-related mortality [during 5 years]

      for cohort 1

    14. chemotherapy-related mortality [during 5 years]

      for cohort 1

    15. transplant-related mortality [during 5 years]

      for cohort 1

    16. Number of serious adverse events according to WHO classification related to treatment received [during 5 years]

      for cohort 1

    17. Allograft-specific characteristic [during 5 years]

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

    18. number of progression to ATL [at 2 years]

    19. Number of progression to ATL [At 5 years]

    20. number of patients with HTLV-1-related extrahematological disorders [during 5 years]

    21. 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

    22. Number of Serious adverse events according to WHO classification related to treatment received [during 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05237245
    Other Study ID Numbers:
    • APHP180684
    • 2020-A02320-39
    First Posted:
    Feb 14, 2022
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Human T-lymphotropic Virus 1
    lymphoma
    leukemia
    Additional relevant MeSH terms:
    HTLV-I Infections
    Lymphoma
    Leukemia
    Leukemia-Lymphoma, Adult T-Cell

    Study Results

    No Results Posted as of Feb 14, 2022