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

Kyowa Kirin

Status: Enrolling

Conditions: Cutaneous T Cell Lymphoma; ATLL; Leukemia/Lymphoma

Study type: Observational

Funder types: Industry

Identifiers

NCT04014374

SC18-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 2 patient groups

Transplant Arm

Description:

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

Control Arm

Description:

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