Spots Global Cancer Trial Database for Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome

Study Description

Brief Summary: This trial is studying the side effects and how well giving cyclophosphamide and busulfan followed by donor stem cell transplant works in treating patients with myelofibrosis, acute myeloid leukemia, or myelodysplastic syndrome. Giving chemotherapy, such as cyclophosphamide and busulfan, before a donor stem cell transplant helps stops the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after the transplant may stop this from happening

Detailed Description: PRIMARY OBJECTIVES: I. To estimate the incidence of hepatotoxicity with a conditioning regimen of CY (cyclophosphamide)/tBU (busulfan) in patients receiving hematopoietic cell transplant (HCT). SECONDARY OBJECTIVES: I. To determine overall and non-relapse mortality at day +200 after HCT. II. To determine the peak bilirubin levels through day +20 after HCT. III. To determine the incidence of pulmonary toxicity in the form of idiopathic pulmonary syndrome (IPS). IV. To determine the rate of graft failure. V. To determine the time to engraftment. VI. To determine the rate of relapse. VII. To determine the incidence and severity of graft-versus-host disease (GVHD). VIII. To evaluate the pharmacokinetics/dynamics of BU and CY. X. To evaluate the pharmacogenomics of response, toxicity and pharmacokinetics of CY/tBU. OUTLINE: CONDITIONING REGIMEN: Patients receive cyclophosphamide intravenously (IV) on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or orally (PO) twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11. After completion of study treatment, patients are followed periodically.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial