Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Graft -Versus-host-disease
- Acute Myeloid Leukemia in Remission
- Adult Acute Lymphoblastic Leukemia in Complete Remission
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive in Remission
- Severe Aplastic Anemia
- Chronic Myelomonocytic Leukemia in Remission
- Hodgkin Lymphoma
- Minimal Residual Disease
- Waldenstrom Macroglobulinemia
- Myelodysplastic Syndrome
- Myeloproliferative Neoplasm
- Non Hodgkin Lymphoma
- Plasma Cell Myeloma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 79 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the cumulative incidence of extensive chronic graft versus host disease (GVHD) at 1 year after transplantation utilizing the novel conditioning/GVHD prophylactic regimen for patients undergoing allogeneic hematopoietic cell transplantation, in patients who do not ...
PRIMARY OBJECTIVES: I. To determine the cumulative incidence of extensive chronic graft versus host disease (GVHD) at 1 year after transplantation utilizing the novel conditioning/GVHD prophylactic regimen for patients undergoing allogeneic hematopoietic cell transplantation, in patients who do not progress before day 100. SECONDARY OBJECTIVES: I. To evaluate clinical response, engraftment rate, progression-free survival (PFS) at one year and, overall survival (OS). II. To determine the cumulative incidence of relapse. III. To evaluate the day 100 transplant-related mortality rate. IV. To determine the cumulative incidence of grade III-IV acute GVHD. OUTLINE: This is a dose-escalation study of melphalan hydrochloride. CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo total body irradiation (TBI) on day -1. STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and tacrolimus IV and then orally (PO) once tolerated on days 5-180 with a taper beginning on day 100. After completion of study treatment, patients are followed up for 12 months and then annually thereafter.
Tracking Information
- NCT #
- NCT03192397
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Christine Ho Roswell Park Cancer Institute