This phase II trial studies the how well donor stem cell transplant works in treating patients with high risk hematologic malignancies. Giving total-body irradiation and chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also 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. The donated stem cells may also replace the patient’s immune cells and help destroy any remaining cancer cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03032783.
PRIMARY OBJECTIVE:
I. To assess 2 year probability of overall survival (OS) in high risk patients undergoing a myeloablative 2 step hematopoietic stem cell transplantation (HSCT) utilizing strategies to decrease relapse.
SECONDARY OBJECTIVES:
I. To assess relapse incidence at 2 years post-HSCT of patients undergoing treatment on this protocol.
II. To assess regimen related toxicity and graft versus host disease (GVHD) incidence at 2 years post-HSCT and severity in patients undergoing treatment on this protocol.
III. To assess the consistency and pace of engraftment.
IV. To assess the pace of T cell and B cell immune recovery.
OUTLINE:
Patients undergo total body irradiation (TBI) twice daily (BID) on days -10 to -8 and donor lymphocyte infusion (DLI) on day -6. Patients receive cyclophosphamide intravenously (IV) on days -3 and -2, tacrolimus IV beginning on day -1 and then orally (PO) at least 2 or 3 days prior to discharge with taper starting on day 42, and mycophenolate mofetil IV BID on days -1 to 28. Patients undergo HSCT on day 0.
After completion of study treatment, patients are followed up for 2 years.
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorUsama Gergis