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

NCT ID: NCT04014374

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-10

Study Completion Date

2030-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Leukemia/Lymphoma Cutaneous T Cell Lymphoma ATLL

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Transplant Arm

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

No interventions assigned to this group

Control Arm

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CIBMTR

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Linda J Burns, MD

Role: CONTACT

414-805-0714

Jatin Jadwani, BDS, MSc Clinical Research

Role: CONTACT

+49 15114861167

Other Identifiers

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SC18-09

Identifier Type: -

Identifier Source: org_study_id

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