Stem Cell Transplantation for Hematological Malignancies

• Status: Terminated
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This protocol using busulfan, cyclophosphamide and melphalan has been designed as conditioning therapy for patients receiving stem cell transplantation for acute leukemia or myelodysplastic syndrome (MDS). The hypothesis is that this new regimen will be well tolerated and will cure the patient.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Antilymphocyte Serum; Busulfan; Cyclophosphamide; Lenograstim; Melphalan; Sargramostim

Criteria

Inclusion Criteria:

• Patients must have a diagnosis of acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and currently be in complete remission.

• Patients must be either:

• - <18 years of age who are at least 6 months after initial hematopoietic cell transplant (HCT),

• - 19-35 years of age and at least 18 months after initial HCT, or

• - <35 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy

• Adequate major organ function including:

• - Cardiac: ejection fraction > or = 45%

• - Renal: creatinine clearance > or = 40 mL/min

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

• - Karnofsky performance status > or = 70% or Lansky score > or = 50%

• Women of child bearing age must be using adequate birth control and have a negative pregnancy test.

• Written informed consent.

Exclusion Criteria:

• Eligible for TBI containing preparative regimen.

• Active uncontrolled infection within one week of HCT.

• Pregnant or lactating females.