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Protocol No. 2005LS075 Principal Investigator Ebens, Christen
Phase Phase II
Age Group Children Scope Local
Secondary Protocol No. MT2005-25
Title MT2005-25 Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia
Objective This phase II trial is studying how well a non-irradiation containing chemotherapy regimen followed by a double umbilical cord blood transplant works in treating infants with high-risk acute leukemia or myelodysplastic syndromes.
Treatment Treatment includes non-irradiation containing myeloablative conditioning regimen and an umbilical cord blood transplant. After completion of study treatment, patients are followed periodically for at least 5 years.
Description Giving chemotherapy, including busulfan, fludarabine, and melphalan, before a double umbilical cord blood stem cell transplant helps as treatment for infant leukemia.
Key Eligibility Patients diagnosed with acute myeloid leukemia , acute lymphoblastic leukemia or myelodysplastic syndrome (in complete remission).
Applicable Disease Sites Acute Lymphocytic Leukemia (ALL)
Acute myeloid leukemia (AML)
Hematologic Malignancies
Lymphoid Leukemia
Myelodysplastic syndromes (MDS)
Therapies Involved Blood and Marrow Transplant
Chemotherapy
Drugs Involved BUSULFAN (MYLERAN)
FLUDARABINE (FLUDARA)
MELPHALAN (ALKERAN)
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Patient must be no more than 2 years of age at the time of diagnosis. Patients with active infection at time of transplantation or history of HIV infection are not eligible. Patients with prior myeloablative transplant within the last 6 months are not eligible. A signed informed consent, assent form and HIPAA authorization are required.
Treatment Type Treatment
Contact Michael Verneris Phone:612-626-2961
Email:verneris@umn.edu