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Observational Study of Mogamulizumab and Stem Cell Transplant for Leukemia/Lymphoma

This study is looking at the safety and side effects of allogeneic hematopoietic stem cell transplantation (alloHCT), also known as a stem cell transplant, in people who have been treated with a medicine called mogamulizumab. Mogamulizumab is used for certain types of leukemia and lymphoma, specifically Cutaneous T-Cell Lymphoma (CTCL) or Adult T-Cell Leukemia/Lymphoma (ATLL). Researchers want to understand if there are any toxicities (harmful effects) or complications from the transplant in patients who received mogamulizumab either before or after their transplant. You might be able to join if you are an adult (18 or older) with CTCL or ATLL, have had an alloHCT since January 2012, and are registered with the CIBMTR (Center for International Blood and Marrow Transplant Research). The study is ongoing, but the current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information about your health without giving you a specific treatment. It is a retrospective and prospective study, looking at past and future data, and plans to include 150 participants.
What's involved
Data will be collected at the start of the study (looking back at your history), and then at 100 days, 6 months, 1 year, and 2 years after your stem cell transplant.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for data collection up to 2 years after their stem cell transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04014374

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

Recruiting
Not specifiedAges 18+Observational
Kyowa Kirin, Inc.
~150 participants
Updated 2024-07-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination
Measured over one year prior to alloHCT to within 18 months after alloHCT

Conditions

Leukemia/Lymphoma
Cutaneous T Cell Lymphoma
ATLL

Explore related trials

Adult T-Cell Leukemia/LymphomaPrimary Cutaneous T-Cell Non-Hodgkin Lymphoma

NCT04014374

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • CIBMTR

    Milwaukee, Wisconsinno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Linda J Burns, MD
[email protected]
414-805-0714
Email the study team

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combinationone year prior to alloHCT to within 18 months after alloHCT

    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.