Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Fred Hutchinson Cancer Research Center; M.D. Anderson Cancer Center; Otsuka Pharmaceutical Co., Ltd.
• Treatments: Busulfan; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

Inclusion Criteria:

• Patients ages between 0 to and 65 years of age.

• Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.

• Acute lymphocytic leukemia (ALL) in CR1 with high risk features

• Acute myeloid leukemia (AML) in CR1 with high risk features defined as:

i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities]

• Acute Leukemias in 2nd or greater remission

• Refractory or Relapsed AML

• AML transformed from MDS

• Myelodysplastic syndrome (MDS) beyond refractory anemia

• Chronic myeloid leukemia (CML)

• Chronic myelomonocytic leukemia

• Philadelphia-negative myeloproliferative disorder

• Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma

• Multiple Myeloma-Stage III

Exclusion Criteria:

• Prior autologous or allogeneic stem cell transplant.

• Performance status greater than 2

• Active infection.

• Inadequate cardiac function; arrythmias or symptomatic cardiac disease.

• Inadequate pulmonary function; FEV1, FVC, DLCO <50% of predicted

• Inadequate Serum creatinine clearance <60

• InadequatebHepatic function

• Positive serology for HIV-1, 2 or HTLV-1, 2.

• Pregnancy. Female patient must have negative pregnancy test