Multi-institutional Prospective Research of Expanded Multi-antigen Specifically Oriented L
This Phase I dose-escalation trial is designed to evaluate the safety of administering rapidly -generated tumor multi-antigen associated -specific cytotoxic T lymphocytes, to HSCT recipients with high risk AML and MDS.
| Condition(s) | Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This Phase I dose-escalation trial is designed to evaluate the safety of administering rapidly -generated tumor multi-antigen associated -specific cytotoxic T lymphocytes, to HSCT recipients with high risk AML and MDS. |
| Who can participate | Recipient Inclusion Criteria to Enter Protocol: * Aged 6 months to 80 years. * Anticipated myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant. * Patients with high risk AML and MDS who have received or will receive an allo-HSCT and have not had hematologic relapse of disease. * Karnofsky/Lansky score of ≥ 50. * Agree to use contraceptive measures during study protocol participation (when age appropriate). * Patient or parent/guardian capable of providing informed consent. * T cell chimerism \> 94% if collected from recipient of allo-HSCT Recipient Exclusion Criteria to Enter Protocol: * Patients with uncontrolled infections. * Current evidence of GVHD \> grade 2 or bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis. * Pregnancy (female of childbea |
| Ages | 6 Months to 80 Years |
| Sex | All |
| Lead sponsor | Catherine Bollard |
| Locations | Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States |
| Start date | 2015-01-01 |
| NCT ID | NCT02203903 |
| Official listing | https://clinicaltrials.gov/study/NCT02203903 |