Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood Transplantation

Central Venous Catheter Placement: You will first have a central venous catheter (CVC) placed. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for it. The chemotherapy, some of the other drugs in this study, and the cord blood transplant will be given by vein through your CVC. Blood samples will also be drawn through your CVC. The CVC will remain in your body for about 2-5 months. Study Plans: If you agree to take part in this study, your doctor will choose one of the following 2 study plans based on the disease and your age and medical history. Fludarabine/Clofarabine/Busulfan/Rituximab/Total Body Irradiation: If you are between 1 and 80 years of age and can receive high-dose chemotherapy, and your doctor agrees, you will receive fludarabine, clofarabine, busulfan, ATG, total body irradiation, and possibly rituximab. If you are receiving this study plan medication, blood may be drawn to check levels of busulfan 1 or more times over the 4-day course of treatment. No more than 1 teaspoon will be taken at each blood draw. Day Treatment * Day0 Admit, IV hydration, rituximab 375 mg/m2 (B cell malignancy) * Day1 Fludarabine 10 mg/m2, clofarabine 30 mg/m2, busulfan AUC 5,000 * Day2 Fludarabine 10 mg/m2, clofarabine 30 mg/m2, busulfan AUC 5,000 * Day3 Fludarabine 10 mg/m2, clofarabine 30 mg/m2, busulfan AUC 5,000 * Day4 Fludarabine 10 mg/m2, clofarabine 30 mg/m2, busulfan AUC 5,000, rabbit ATG 1.25 mg/kg * Day5 Low-dose TBI 2 Gy in AM, rabbit ATG 1.75 mg/kg * Day6 Rest * Day7 Rest * Day8 Cord blood infusions Fludarabine, Melphalan Day Treatment * Day0 Admit, hydration * Day1 Fludarabine 40 mg/m2 IV * Day2 Fludarabine 40 mg/m2 IV, rabbit ATG 1.25 mg/kg * Day3 Fludarabine 40 mg/m2 IV, rabbit ATG 1.75 mg/kg * Day4 Fludarabine 40 mg/m2 IV and Melphalan 140 mg/m2 IV * Day5 Rest * Day6 Cord blood infusions Supportive Drugs: Starting on Day -3, you will receive mycophenolate mofetil as a tablet by mouth 2 times a day. If you are not able to take the tablet by mouth, you will receive MMF by vein over 2 hours 2 times a day. If you do not have GVHD at Day 100 after your cord blood transplant, the dose of MMF will be gradually lowered. If you have GVHD, MMF may be stopped 7 days after the GVHD is controlled. Starting on Day -2, you will receive tacrolimus by vein as a continuous (nonstop) infusion until you are able to take it by mouth. You will then take tacrolimus by mouth 2 times a day for about 6 months. After that, your tacrolimus dose may be gradually lowered if you do not have GVHD. Your doctor will discuss this with you. Starting on Day 0, you will receive filgrastim (G-CSF) through a needle under the skin 1 time a day every day until your white blood count begins to recover. Filgrastim is designed to help cells in the bone marrow to divide, which helps raise white blood cells counts more quickly, lower fever, and decrease the risk of infection. Study Visits: At about 6 weeks, 3, 6, and 12 months after the transplant: * You will have a physical exam. * You will be checked for possible reactions to the transplant and study drugs, including GVHD. * Blood (about 4 teaspoons) will be drawn for routine tests, to check for CMV antibodies, and for genetic tests to learn if the donor's cells have "taken". The routine blood tests will be repeated as often as the doctor thinks is needed. * If the doctor thinks it is needed, you will have a bone marrow aspiration to check the status of the disease. You will need to stay in the hospital for about 4 weeks. After you leave the hospital, you will continue as an outpatient in the hospital area, which means you will have to stay close enough to be able to come back for any visits for about 100 days after the transplant. Length of Participation: If the study suits you and you agree to join, you will be in it for one year after your transplant. You will be taken off study early if the disease gets worse, if intolerable side effects occur, if the cord blood is infected and cannot be transplanted, if you are unable to follow study directions, or if your doctor thinks it is in your best interest. This is an investigational study. Fucosylation is not an FDA-approved process. It is currently being used for research purposes only. Fludarabine, busulfan, clofarabine, melphalan, mycophenolate mofetil, tacrolimus, and rituximab are FDA approved and commercially available to be given to patients with leukemia or lymphoma having a cord blood transplant. Total body irradiation is delivered using FDA-approved and commercially available methods. Up to 25 patients will be enrolled in this study. All will be enrolled at M.D. Anderson Cancer Center, Scripps Green Hospital,University Hospitals Case Medical Center, and Texas Transplant Institute.