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

NCT04014374 | Recruiting

• 1 other identifier: SC18-09
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients without consent for research.

Sponsors & Collaborators

• Kyowa Kirin, Inc.: lead

Study Sites (1)

CIBMTR

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Leukemia; Lymphoma; Lymphoma, T-Cell, Cutaneous; Leukemia-Lymphoma, Adult T-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Leukemia, T-Cell; Leukemia, Lymphoid

Central Study Contacts

Linda J Burns, MD

CONTACT

414-805-0714; lburns@mcw.edu

Jatin Jadwani, BDS, MSc Clinical Research

CONTACT

+49 15114861167; jatin.jadwani@kyowakirin.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 10, 2019
• Study Start: September 10, 2019
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)