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Protocol No. 1999LS073 Principal Investigator MacMillan, Margaret
Phase Phase I/II
Age Group Children Scope Local
Secondary Protocol No. MT1999-20
Title MT1999-20 Hematopoietic cell transplantation in children with juvenile myelomonocytic leukemia
Objective This phase II trial is studying how well giving busulfan and cyclophosphamide together with melphalan works in treating young patients who are undergoing a donor bone marrow transplant or an umbilical cord transplant for juvenile myelomonocytic leukemia.
Treatment Preparative therapy: Patients receive busulfan IV, cyclophosphamide IV, and melphalan IV. Patients who undergo umbilical cord blood transplantation also receive anti-thymocyte globulin IV. Allogeneic hematopoietic stem cell transplantation: Patients undergo allogeneic bone marrow or umbilical cord blood transplantation. Post-transplant therapy: Patients receive cyclosporine IV followed by a taper starting at day 100. Patients who have an umbilical cord blood donor also receive mycophenolate mofetil IV. Patients who have a bone marrow donor also receive methotrexate IV. All patients receive oral isotretinoin once a day beginning on day 60 and continuing for 1 year. After completion of study treatment, patients are followed periodically.
Description Giving chemotherapy drugs, such as busulfan, cyclophosphamide, and melphalan, before a donor bone marrow transplant or an umbilical cord transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's 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.
Key Eligibility Diagnosis of juvenile myelomonocytic leukemia (JMML) meeting protocol criteria.
Applicable Disease Sites Bone Marrow
Juvenile myelomonocytic leukemia (JMML)
Leukemia
Therapies Involved Blood and Marrow Transplant
Chemotherapy
Drugs Involved BUSULFAN (MYLERAN)
CYCLOPHOSPHAMIDE (CYTOXAN, NEOSAR)
MELPHALAN (ALKERAN)
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Must be less than 18-years-old. Must have a HLA-matched, related or unrelated donor available, determined by class I antigens (HLA-A and -B) and class II antigens (DRB1 or DR [if parental typing available]), meeting protocol criteria. A signed informed consent and HIPAA authorization are required; assent form is also required for minors.
Treatment Type Other
Contact Timothy Krepski Phone:612-273-2800
Email:tkrepsk1@fairview.org