Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKyowa Kirin, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: Transplant Arm
Group B: Control Arm
Trial outcomes
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.
Time frame
one year prior to alloHCT to within 18 months after alloHCTSponsors and contacts
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Source ClinicalTrials.gov