Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
A Phase II Study to Evaluate the Efficacy of Posttransplant Cyclophosphamide for Prevention of Chronic Graft-versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation
This phase II trial studies how well cyclophosphamide works in preventing chronic graft-versus-host disease after allogeneic peripheral blood stem cell transplant in patients with hematological malignancies. Giving chemotherapy and total-body irradiation before transplantation helps stop the growth of cancer cells and prevents the patient's immune system from rejecting the donor's stem cells. Healthy stem cells from a donor that are infused into the patient help the patient's bone marrow make blood cells; red blood cells, white blood cells, and platelets. Sometimes, however, the transplanted donor cells can cause an immune response against the body's normal cells, which is called graft-versus-host disease (GVHD). Giving cyclophosphamide after transplant may prevent this from happening or may make chronic GVHD less severe.
PRIMARY OBJECTIVES:
I. The primary objective of this study is to assess outcomes when high-dose cyclophosphamide
(CY) is administered on days 3 and 4 followed by cyclosporine (CSP) after human leukocyte
antigen (HLA)-matched related or unrelated mobilized blood cell transplantation with
total-body irradiation (TBI) or busulfan (BU)-based conditioning.
SECONDARY OBJECTIVES:
I. The secondary objective of this study is to assess hematopoietic cell transplantation
(HCT) outcomes when withdrawal of CSP is accelerated in patients without acute
graft-versus-host disease (GVHD).
OUTLINE: Patients' conditioning regimens are determined by the Clinical Coordinator after
consultation with the attending physician. Based on disease, patients receive either TBI or
fludarabine and busulfan.
PREPARATIVE REGIMEN: Patients receive TBI twice daily (BID) on days -4 or -3 to -1. Some
patients also receive fludarabine intravenously (IV) daily on days -5 to -2 and busulfan IV
over 3 hours once daily (QD) or over 2 hours every 6 hours on days -5 to -2. Patients may
also undergo central nervous system (CNS) prophylaxis, testicular irradiation, and/or
involved field irradiation as per standard practice.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation
(PBSCT) on day 0 per standard practice.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients
also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper
on days 56-126.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at day 180 and then annually
for 5 years.
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