An observational study in Leukemia/Lymphoma, Cutaneous T Cell Lymphoma and ATLL, sponsored by Kyowa Kirin, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Kyowa Kirin, Inc. · Observational
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.
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.
31 studies on the registry are indexed under Leukemia-Lymphoma, Adult T-Cell; 5 are open to participants now.
Browse Leukemia-Lymphoma, Adult T-Cell studies →Kyowa Kirin, Inc. is the lead sponsor of 36 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Compared within Leukemia-Lymphoma, Adult T-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Leukemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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Exclusion Criteria:
Patients with CTCL or ATLL who received mogamulizumab within one year prior or up to 18 months after alloHCT
Patients who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT
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 alloHCT
Plan to share: No
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Leukemia-Lymphoma, Adult T-Cell →