ATLL, Cutaneous T Cell Lymphoma, Leukemia/Lymphoma
Conditions
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.
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.
Interventions
None listed
Sponsors
Kyowa Kirin, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination | one 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. |
Countries
United States
Contacts
Primary ContactLinda J Burns, MD
Backup ContactJatin Jadwani, BDS, MSc Clinical Research
Outcome results
None listed