Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for… (NCT03093844) | Clinical Trial Compass
CompletedNot Applicable
Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders
United States150 participantsStarted 2017-10-12
Plain-language summary
This is a study to evaluate the safety and efficacy of Miltenyi CliniMACS® CD34 Reagent System to promote engraftment of haploidentical CD34+ selected cells combined with single unit umbilical cord blood transplant for treatment of high-risk hematologic disorders.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria - Recipient
* Ages 18-80 years inclusive
* Diagnosed with high risk hematologic disorders warranting stem cell transplant per institutional standard of care
* Lack HLA-identical related donor
* Availability of at least one HLA- haploidentical (i.e. =\> 5/10 and \<= 8/10 HLA match) related donor (HLA-A, B, C, DR, and DQ loci) who is available to donate CD34+ cells.
* Availability of at least one 4/6 HLA-matched (HLA-A, B, and DR loci) cord blood unit from the National Marrow Donor Program (NMDP). The cord blood unit must contain a minimum TNC (prior to thawing) of at least 2x107 cells per kilogram of recipient body weight
* Ability to comprehend the nature of the treatment 6.2. Exclusion Criteria - Recipient (any of the following)
* HLA identical (6/6) related donor available and readily accessible at time of transplantation evaluation
* Any patient not meeting institutional standard guidelines for transplant eligibility
What they're measuring
1
The Number of Patients With Successful Engraftment