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Protocol No. 2005LS043 Principal Investigator Brunstein, Claudio
Phase Phase II
Age Group Both Scope Local
Secondary Protocol No. MT2005-10
Title MT2005-10 Transplantation of Unrelated Umbilical Cord Blood for Patients with Hematological Diseases with Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloblative Preparative Regimen
Objective This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an umbilical cord blood transplant for hematologic cancer.
Treatment Patients will receive chemotherapy drugs (preparative regimen), immuosuppressive drugs, irradiation, growth hormone and umbilical cord blood transplantation. After completion of study treatment, patients are followed periodically for at least 5 years.
Description Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil may stop this from happening.
Key Eligibility Patients with diagnosis of hematologic malignancy - acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), advanced myelofibrosis, myelodysplastic syndrome (MDS), chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PML), multiple myeloma, or non-Hodgkin's lymphoma (NHL) are eligible.
Applicable Disease Sites Acute Lymphocytic Leukemia (ALL)
Acute myeloid leukemia (AML)
Chronic lymphocytic leukemia (CLL)
Chronic myeloid leukemia (CML)
Hematologic Malignancies
Lymphoid Leukemia
Multiple Myeloma
Myelodysplastic syndromes (MDS)
Myeloproliferative diseases (MPD)
Non-Hodgkin's Lymphoma
Therapies Involved Blood and Marrow Transplant
Chemotherapy
Total Body Irradiation (TBI)
Drugs Involved CYCLOPHOSPHAMIDE (CYTOXAN, NEOSAR)
CYCLOSPORIN
FILGRASTIM (G-CSF, NEUPOGEN)
FLUDARABINE (FLUDARA)
MYCOPHENOLATE MOFETIL
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Patient must be no more than 55 years of age. Must have HLA matched unrelated umbilical cord blood (UCB) donor available Certain laboratory ranges must be met. Patients with active infection at the time of transplantation or history of HIV are not eligible. Women who are pregnant or nursing are not eligible. Males and females of reproductive potential must agree to use effective contraception. A signed informed consent and HIPAA authorization are required; assent is also required in case of minors.
Treatment Type Treatment
Contact Timothy Krepski Phone:612-273-2800
Email:tkrepsk1@fairview.org