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Protocol No. 2001LS058 Principal Investigator Warlick, Erica
Phase Phase II (Cancer Prevention)
Age Group Both Scope Local
Secondary Protocol No. MT2001-10
Title MT2001-10 Allogeneic Bone Marrow Transplant Using Less Intensive Therapy
Objective This clinical trial is studying how well giving a reduced amount of combination chemotherapy together with radiation therapy followed by cyclosporine and mycophenolate mofetil works in treating patients who are undergoing a donor stem cell transplant for hematologic cancer or kidney cancer.
Treatment Patients receive cyclophosphamide, and fludarabine and total body irradiation prior to transplant. Some patients also receive anti-thymocyte globulin (ATG). Patients undergo allogeneic peripheral blood stem cell transplantation (PBSCT). Patients receive cyclosporine and mycophenolate mofetil prior to and after transplant. After completion of study treatment, patients are followed periodically for 2 years.
Description A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy, or that have become cancer. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclophosphamide and fludarabine together with total-body irradiation followed by cyclosporine and mycophenolate mofetil before the transplant may stop this from happening.
Key Eligibility Patient must have a diagnosis of 1 of the following (meeting criteria outlined in the protocol): *Acute myeloid leukemia (AML) *Acute lymphocytic leukemia (ALL) *Chronic myelogenous leukemia (CML) *Non-Hodgkin's lymphoma (NHL) *Hodgkin's lymphoma *Chronic lymphocytic leukemia *Acquired bone marrow failure syndromes *Multiple myeloma *MDS of all subtypes including refractory anemia if severe pancytopenia or high-risk cytogenetics * Metastatic breast cancer responsive to recent chemotherapy or in plateau after response to chemotherapy * Renal cell cancer * Chronic myeloproliferative disorder (e.g., myelofibrosis)
Applicable Disease Sites Acute Lymphocytic Leukemia (ALL)
Acute myeloid leukemia (AML)
Bone Marrow
Chronic lymphocytic leukemia (CLL)
Chronic myeloid leukemia (CML)
Hodgkin's Lymphoma
Kidney
Lymphoid Leukemia
Multiple Myeloma
Myelodysplastic syndromes (MDS)
Myeloproliferative diseases (MPD)
Non-Hodgkin's Lymphoma
Therapies Involved Blood and Marrow Transplant
Chemotherapy
Drugs Involved CYCLOPHOSPHAMIDE (CYTOXAN, NEOSAR)
FLUDARABINE (FLUDARA)
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Patient must be less than 70-years-old. Donors must be 5/6 or 6/6 related match OR 7-8/8 HLA-A,-B, -C, -DRB1 allele unrelated volunteer match. Patients with refractory leukemia or MDS may undergo transplant in aplasia after induction or re-induction chemotherapy or radiolabeled antibodies. Women who are pregnant or nursing are not eligible. Males and females of reproductive potential must agree to use effective contraception. Known HIV or other active serious infection is not allowed. A signed informed consent and HIPAA authorization is required; assent form required for minors.
Treatment Type Treatment
Contact Timothy Krepski Phone:612-273-2800
Email:tkrepsk1@fairview.org