Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Appropriate diagnosis: Patients must have a disease or syndrome amenable to therapy with hematopoietic stem cell transplantation. Diagnoses include, but are not limited to:
- * Congenital and Other Non-malignant Disorders:
- * Immunodeficiency disorders (e.g. Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome)
- * Congenital hematopoietic stem cell defects (e.g. Chediak-Higashi Syndrome, Congenital Osteopetrosis, Osteogenesis Imperfecta)
- * Metabolic disorders (e.g. Hurler's Syndrome)
- * Severe aplastic anemia
- * High-Risk Leukemia:
- * Acute Myelogenous Leukemia
- * Refractory to standard induction therapy (more than 1 cycle required to achieve remission)
- * Recurrent (in CR ≥ 2)
- * Treatment-related AML or MDS
- * Evolved from myelodysplastic syndrome
- * Presence of FLT3 abnormalities
- * FAB M6 or M7
- * Adverse cytogenetics
- * Myelodysplastic Syndrome
- * Acute Lymphoblastic Leukemia including T lymphoblastic leukemia:
- * Refractory to standard induction therapy (time to CR \>4 weeks)
- * Recurrent (in CR ≥ 2)
- * WBC count \>30,000/mcL at diagnosis
- * Age \>30 at diagnosis
- * Adverse cytogenetics, such as t(9:22), t(1:19), t(4:11), and other MLL rearrangements.
- * Chronic Myelogenous Leukemia in accelerated phase or blast crisis
- * Biphenotypic or undifferentiated leukemia
- * Burkitt's leukemia or lymphoma
- * Lymphoma:
- * Large cell, Mantle cell, Hodgkin lymphoma refractory or recurrent, chemo-sensitive, and ineligible for an autologous stem cell transplant or previously treated with autologous SCT
- * Marginal zone or follicular lymphoma that is progressive after at least two prior therapies
- * Multiple Myeloma, recurrent following high-dose therapy and autologous SCT or ineligible for an autologous HSCT
- * Solid tumors, with efficacy of allogeneic HSCT demonstrated for the specific disease and disease status
- * Adequate organ function:
- * Cardiac - LVEF \>45%, or shortening fraction \>25%, Absence of congestive heart failure or conduction disturbances with high risk for sudden death
- * Pulmonary - DLCO (corrected for hemoglobin), FEV1 and FVC ≥ 50% predicted;
- * Renal - serum Cr \< 1.5 times the upper limit of normal for age or GFR ≥ 50 ml/min/1.73m2
- * Hepatic - total bilirubin level \< 2 times the upper limit of normal (except for patients with Gilbert's syndrome or hemolysis); if the primary disease process is causal, this criterion will be reconsidered. ALT, AST, and Alkaline phosphatase ≤ 5 times upper limit of normal.
- * Performance Status Karnofsky or Lansky score ≥ 70%.
- * Informed Consent must be obtained prior to initiating conditioning therapy.
- * Receipt of viable cord blood product(s), single or dual, must be confirmed with the stem cell processing laboratory prior to initiating conditioning therapy.
- * Availability of 10/10 or 9/10 HLA-matched related or unrelated donor within a reasonable timeframe dictated by the clinical urgency of the transplant
- * Autologous HSCT \< 6 months prior to proposed UCB transplant
- * Pregnant or breast feeding
- * Current uncontrolled infection
- * Evidence of HIV infection or positive HIV serology
Ages Eligible for Study
2 Months to 75 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No