At a glance
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Allogeneic Stem Cell Transplant With a Novel Conditioning Therapy Using Helical Tomotherapy, Melphalan, and Fludarabine in Hematological Malignancies
In Brief
A Phase 2 clinical trial evaluating fludarabine phosphate, melphalan, and 2 other interventions for Leukemia and Myelodysplastic Syndromes. Active but no longer recruiting, targeting 75 participants across 1 site.
Detailed Summary
RATIONALE: Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and HT before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving HT together with fludarabine phosphate and melphalan before a transplant may stop this from happening. PURPOSE: This clinical trial studies helical tomotherapy (HT), fludarabine phosphate, and melphalan followed by donor stem cell transplant in treating patients with hematologic malignancies.
Study Details
Timeline
Interventions
25 mg/m2 day -7 through day -3 prior to transplant
140 mg/m2 day -2 prior to transplant
Cells infused on Day 0 of transplant regimen
Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant