Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02122081

Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

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.

Status: 
Recruiting
Study Date: 
Mon, 06/01/2015 to Wed, 11/01/2017
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Radiation: radiation therapy Undergo organ-sparing marrow irradiation BID on days -6 to -4 Other Names: irradiation radiotherapy therapy, radiation Drug: cyclophosphamide Given IV over 1-2 hours every 24 hours on days -3 to -2. Other Names: CPM CTX Cytoxan Endoxan Endoxana Biological: anti-thymocyte globulin Other Names: ATG ATGAM lymphocyte immune globulin Thymoglobulin Drug: tacrolimus Given IV or PO Other Names: FK 506 Prograf Drug: methotrexate Given IV Other Names: amethopterin Folex methylaminopterin Mexate MTX Procedure: allogeneic bone marrow transplantation Undergo allogeneic peripheral blood progenitor cell or bone marrow transplant on day 0 Other Names: bone marrow therapy, allogeneic bone marrow therapy, allogenic transplantation, allogeneic bone marrow transplantation, allogenic bone marrow Procedure: allogeneic hematopoietic stem cell transplantation Undergo allogeneic peripheral blood progenitor cell or bone marrow transplant Procedure: peripheral blood stem cell transplantation Undergo allogeneic peripheral blood progenitor cell or bone marrow transplant Other Names: PBPC transplantation PBSC transplantation peripheral blood progenitor cell transplantation transplantation, peripheral blood stem cell Other: laboratory biomarker analysis Correlative studies