Unrelated Umbilical Cord Blood (UBC)Transplantation
Chronic Myelogenous Leukemia (CML), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome
About this trial
This is an interventional treatment trial for Chronic Myelogenous Leukemia (CML) focused on measuring Chronic myelogenous leukemia (CML), Acute myelogenous leukemia (AML), Myelodysplastic syndrome, Multiple myeloma, Hodgkin lymphoma, Non Hodgkin lymphoma, Chronic lymphocytic leukemia (CLL), Acute lymphocytic leukemia (ALL), Severe Aplastic Anemia, Cord Blood, Umbilical cord blood transplantation, UBC transplantation
Eligibility Criteria
Inclusion Criteria:
- Age: 16-70 years
- Available 4/6, 5/6, or 6/6 HLA antigen match (using A, B, and DRB1) cord blood unit.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky greater than or equal to 70%)
- Serum bilirubin less than 2 x upper limit of normal
- Serum creatinine less than 2 mg/dl
- DLCO or FEV1 greater than or equal to 50% predicted
- Left ventricular ejection fraction greater than or equal to 35%
- no uncontrolled infection
- If female, not pregnant
- Informed consent given
- No major organ dysfunction precluding transplantation.
One of the following malignancies or bone marrow failure syndromes:
- Chronic myelogenous leukemia (CML)
- Acute myelogenous leukemia (AML)
- Myelodysplastic syndrome
- Multiple myeloma
- Hodgkin lymphoma
- Non-Hodgkin lymphoma
- Chronic lymphocytic leukemia (CLL)
- Acute lymphocytic leukemia (ALL)
- Severe Aplastic Anemia
Exclusion Criteria:
- Patient pregnant
- Age less than 16, greater than 70
- ECOG performance status of greater than 2 (Karnofsky less than 70%)
- Psychiatric disorder or mental deficiency of the patient sufficiently severe as to make compliance with the BMT treatment unlikely, or making informed consent impossible
- Serum bilirubin greater than or equal to 2 x upper limit of normal, transaminases greater than 3 x upper limit of normal
- Serum creatinine greater than or equal to 2 mg/dl
- DLCO less than 50% predicted
- Left ventricular ejection fraction less than 35%
- Major anticipated illness or organ failure incompatible with survival from Bone Marrow Transplant (BMT)
Sites / Locations
- West Virginia University Hospitals Mary Babb Randolph Cancer Center
Arms of the Study
Arm 1
Experimental
Transplant
After a preparative regimen the patient will receive an infusion of one or two umbilical cord blood unit(s) (UBC). The UBC unit(s) will be thawed according to methods of Rubinstein et al. If two products are used, they will be administered sequentially on the same day 1-6 hours apart. Tacrolimus and mycophenolate mofetil (MMF) will be used for GVHD prophylaxis. On day +30, +60, +100, +180, and +365 the chimeric status of patients will be interpreted by variable number tandem repeat (VNTR) analysis. Immune reconstitution (Digeorge Panel) will also be checked at these time points.