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

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.

Study Overview

• Status: Recruiting
• Conditions: Cutaneous T Cell Lymphoma; ATLL; Leukemia/Lymphoma

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Linda J Burns, MD; Phone Number: 414-805-0714; Email: lburns@mcw.edu
• Study Contact Backup: Name: Jatin Jadwani, BDS, MSc Clinical Research; Phone Number: +49 15114861167; Email: jatin.jadwani@kyowakirin.com

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • CIBMTR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will include a minimum of 50 patients with CTCL or ATLL who received mogamulizumab within one year prior to alloHCT. At least 40 patients should have been diagnosed with CTCL and at least 33 patients should have received mogamulizumab as last therapy line before alloHCT. Data will be collected from no more than 100 controls with similar characteristics to the mogamulizumab-treated patients, and who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT. Information on patients receiving mogamulizumab within 18 months after alloHCT will also be collected.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kyowa Kirin, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Lymphoma; Lymphoma, T-Cell, Cutaneous
• Other Study ID Numbers: SC18-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No