Unrelated Umbilical Cord Blood (UBC)Transplantation

In brief

Hematopoietic progenitor cell (HPC- primitive cells in the blood, bone marrow and umbilical cord that can restore the bone marrow) transplant can be a curative therapy for the treatment of hematologic malignancies (a disease of the bone marrow and lymph nodes). The source of cells used for the transplant comes from related (sibling) and in cases where there is no sibling match, from unrelated donors through the National Marrow Donor Program. The availability of a suitable donor can be a significant obstacle for patients who need a transplant but do not have a matched donor. Cord blood that has been harvested from an umbilical cord shortly after birth has a rich supply of cells needed for transplant. These stored cord bloods are now being used to transplant adults without a matched donor Advantages to using cord blood includes a readily available source of cells with no risk to the donor during the collection process, immediate source of cells in urgent situations (no lengthy donor work-up)and a reduction in infectious disease transmission to the recipient. One of the main disadvantages is the cord blood has a small number of cells needed for transplant. In an adult, usually two cords are needed and large recipients do not qualify because they need too many cells. This study will use two different preparative regimens (chemotherapy and radiation) followed by one or two umbilical cord units (UBC). The preparative regimen used will be chosen by the physician and is based on patient's age, disease and medical condition at the time of transplant. Multiple objectives for this study include disease-free and overall survival, treatment related mortality, rate of cells taking hold, and the incidence and severity of the transplant complication called graft versus host disease (GVHD).

Key facts

Study ID: NCT01768845
Run by: West Virginia University
People needed: 34
Starts: 2009-02-03
Expected to finish: 2021-04-06
Last updated by the study team: 2021-06-14

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

West Virginia University Hospitals Mary Babb Randolph Cancer Center — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.