Recruitment

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