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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Kyowa Kirin, Inc.
Study ID
NCT04014374
Status
Recruiting
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Conditions

  • ATLL
  • Cutaneous T Cell Lymphoma
  • Leukemia/Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Sep 10, 2019
Status verified
Jul 2024
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Transplant Arm
    Patients with CTCL or ATLL who received mogamulizumab within one year prior or up to 18 months after alloHCT
  • Arm: Control Arm
    Patients who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CIBMTRMilwaukeeWisconsin53226-

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By research site
CIBMTR· Milwaukee, WI

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