Recruiting

Mogamulizumab

Sponsor:

Kyowa Kirin, Inc.

Code:

NCT04014374

Conditions

Leukemia/Lymphoma

Cutaneous T Cell Lymphoma

ATLL

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Leukemia/Lymphoma

Cutaneous T Cell Lymphoma

ATLL

Study ID

NCT04014374

Start date

Sep 10, 2019

Status verified date

Jul, 2024

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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 and Locations

Central contacts

Linda J Burns, MD

414-805-0714lburns@mcw.edu

Jatin Jadwani, BDS, MSc Clinical Research

+49 15114861167jatin.jadwani@kyowakirin.com

Locations

CIBMTR

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Kyowa Kirin, Inc.

Last update posted

Jul 24, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kyowa Kirin, Inc. on 2024-07-24.