CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
umbilical cord blood (UCB)genetic
Likely dose
Not stated in record
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Search/NCT01768845
NCT01768845N/ACompleted

Unrelated Umbilical Cord Blood (UCB) Transplantation

West Virginia University·interventional·Posted Jan 15, 2013·Updated Jun 14, 2021

In Brief

A clinical study evaluating umbilical cord blood (UCB) for Chronic Myelogenous Leukemia (CML) and 8 related conditions. Completed, enrolled 34 participants across 1 site.

Detailed Summary

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).

Study Details

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2013
Enrollment StartFeb 3, 2009
Primary CompletionMay 14, 2019
Study CompletionApr 6, 2021
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 13.5 years ago

Interventions

umbilical cord blood (UCB)genetic

Infusion will occur after preparative regimen in one or two UCB unit(s). 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.