Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults
ConditionHematologic Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-60
SponsorAlice Bertaina
About this trial
The purpose of the CliniMACS® TCRαβ-Biotin System and CliniMACS® CD19 is to improve the safety and efficacy of allogeneic HLA-partially matched related or unrelated donors HSCT when no matched donors are available, to treat malignant and nonmalignant disorders for which HSCT is the recommended best available therapy. Initially this device will be used in a single-center, open-label, single-arm, phase II clinical trial to evaluate the efficacy of haploidentical PBSC grafts depleted of TCRα/β+ and CD19+ cells using the CliniMACS® TCRαβ/CD19 System in children and adults with hematological and non-hematological malignancies.
Eligibility criteria
Qualifiers
Age < 60 years and > 1 month;
Life expectancy > 10 weeks;
Patients deemed eligible for allogeneic HSCT per institutional guidelines;
Patients with life-threatening hematological malignancies and non-malignant disorders that could benefit from HSCT;
Disqualifiers
Pregnant or lactating females;
Has received a prior allogenic HSCT;
Secondary MDS or AML or treatment related MDS or AML;
Dysfunction of liver (ALT/AST > 10 times upper normal value, or direct bilirubin > 3 times upper normal value),
Trial design
Treatments tested in this trial
- Allogeneic Stem Cell Transplant
- CliniMACS TCR α/β Reagent Kit and CliniMACS CD19
Treatment groups
204 Participants
are divided into 3 treatment groupsSponsors and collaborators
Alice Bertaina
Lead sponsor
Stanford University
Sponsor institution
Source ClinicalTrials.gov