drugset / Trial / NCT02122081

Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies

NCT02122081

Phase 1 Completed 33 enrolled Sumithira Vasu
NaSingle-groupOpen-labelTreatment

Summary

This pilot clinical trial aims to assess feasibility and tolerability of using an LINAC based "organ-sparing marrow-targeted irradiation" to condition patients with high-risk hematological malignancies who are otherwise ineligible to undergo myeloablative Total body irradiation (TBI)-based conditioning prior to allogeneic stem cell transplant. The target patient populations are those with ALL, AML, MDS who are either elderly (\>50 years of age) but healthy, or younger patients with worse medical comorbidities (HCT-Specific Comorbidity Index Score (HCT-CI) \> 4). The goal is to have the patients benefit from potentially more efficacious myeloablative radiation based conditioning approach without the side effects associated with TBI.

Timeline

Start
2015-07-27
Primary completion
2022-09-06
Completion
2022-09-06

Drugs

EvaluationDrugModalityDoseRoute
Background ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic
Background Cyclophosphamide Other / unclassified Intravenous
Background Methotrexate Small molecule Intravenous
Background Tacrolimus Small molecule Intravenous