Busulfan and Cyclophosphamide Followed By ALLO BMT

• Status: Terminated
• Trial end date: 2020-02-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a treatment guideline to allow routine clinical data to be collected and maintained in Oncore (clinical database) and the University of Minnesota Blood and Marrow Database as part of the historical database maintained by the department.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Allopurinol; Antilymphocyte Serum; Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins; Etiracetam; Lenograstim; Levetiracetam; Mycophenolate mofetil; Mycophenolic Acid; Sargramostim; Tacrolimus

Criteria

Inclusion Criteria:

• Diagnosis of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and current in complete remission meeting one of the following:

• <45 years of age who are at least 6 months after initial hematopoietic stem cell transplant (HSCT)

• <45 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy

• Karnofsky performance status >70% or if <16 years of age, a Lansky play score >50

• Adequate major organ function including:

• cardiac: left ventricular ejection fraction >45% by echocardiogram (ECHO/MUGA)

• renal: creatinine clearance >40 mL/min/1.73m^2

• hepatic: no clinical evidence of hepatic failure (e.g., coagulopathy, ascites)

• An acceptable source of stem cells according to current University of Minnesota Bone Marrow Transplant program guidelines. Acceptable stem cell sources include:

• HLA-matched related or unrelated donor bone marrow (6/6 or 5/6 antigen match)

• HLA-matched related or unrelated donor peripheral blood stem cells

• related or single or double unrelated donor umbilical cord blood (6/6, 5/6 or 4/6 match)

• Women of childbearing age must have a negative pregnancy test and all sexually active participants must agree to use effective contraception during study treatment

• Written consent (adult or parent/guardian)

Exclusion Criteria:

• eligible for TBI containing preparative regimen

• active uncontrolled infection within one week of study enrollment

• pregnant or lactating female