Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Leukemia/Lymphoma, Cutaneous T Cell Lymphoma, ATLL. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- CIBMTR — Milwaukee
Identifiers
NCT: NCT04014374 · SC18-09