About this trial
The goal of this protocol is to expand access for patients who lack a fully HLA (Human leukocyte antigen) matched sibling donor and who are candidates for allogeneic hematopoietic stem cell transplant (HSCT). These patients have a serious or immediately life-threatening disease for which HSCT is indicated. These patients are not eligible for other Children's Hospital of Philadelphia IRB approved protocols that utilize CliniMACs technology for T depletion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who lack a fully HLA matched sibling and who are candidates for allogeneic hematopoietic stem cell transplant (HSCT) but are not deemed suitable candidates per their treating clinical team for current open institutional protocols using ClinMACs device for CD3+/CD19+ depletion.
Signed informed consent
Lansky or Karnofsky performance ≥60
Hematologic and Organ Function per current institutional SOP.
Disqualifiers
Uncontrolled bacterial, viral or fungal infections
Suitable, fully HLA matched sibling donor
Donor unable to donate peripheral stem cells
Pregnant participants
Trial design
Single group
Treatments tested in this trial
Transplant of stem cells with CD3+/CD19+ depletion (CliniMACs)
Biological/VaccineProcessing of stem cells using the CliniMACs device to selectively deplete specific T cells to decrease risk of graft versus host disease when using donor stem cells which are not fully matched.
Treatment groups
Trial outcomes
Primary outcomes
Overall Survival
Number of participants who remain alive.
Secondary outcomes
Graft versus Host Disease
Number of participants who had grades II-IV acute graft versus host disease and/or limited or extensive chronic gvhd
Graft Failure
Number of participants who experienced primary or secondary graft failure or autologous reconstitution.
Sponsors and contacts
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