Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab

Sponsor
Kyowa Kirin, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04014374
Collaborator
(none)
50
1
52.7
0.9

Study Details

Study Description

Brief Summary

This is a non-interventional cohort study evaluating non-relapse mortality and toxicities in patients with CTCL or ATLL treated with mogamulizumab pre- or post- alloHCT for patients transplanted beginning January 1, 2012 until accrual is complete.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is an observational, retrospective and prospective study where subjects who have received mogamulizumab either within one year before or within 18 months after transplantation will be followed for data collection. Data will be collected at baseline (retrospectively), 100 days post alloHCT, 6-months, 1 year and at 2 years post alloHCT (retrospectively and prospectively).

    A cut-off time limit of 18 months post alloHCT exposure will allow at least 6 months of follow-up within the 2 years post-alloHCT follow-up period.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
    Actual Study Start Date :
    Sep 10, 2019
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    Feb 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Transplant Arm

    Patients with CTCL or ATLL who received mogamulizumab within one year prior or up to 18 months after alloHCT

    Control Arm

    Patients who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT

    Outcome Measures

    Primary Outcome Measures

    1. Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination [one year prior to alloHCT to within 18 months after alloHCT]

      This study will utilize comprehensive report form (CRF) data, modified transplant essential data (TED) and supplemental data. In patients with only TED data the supplemental data will provide the required additional information for data analyses to meet the objectives of the study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients registered to the Center for International Blood and Marrow Transplant Research (CIBMTR)

    • Adults ≥18 years of age with either CTCL or ATLL;

    • AlloHCT performed from January 2012 onward.

    Exclusion Criteria:

    • Patients without consent for research.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CIBMTR Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Kyowa Kirin, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyowa Kirin, Inc.
    ClinicalTrials.gov Identifier:
    NCT04014374
    Other Study ID Numbers:
    • SC18-09
    First Posted:
    Jul 10, 2019
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 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

    Study Results

    No Results Posted as of Nov 18, 2021