A Phase 1 interventional study of stem cell transplant and Stem cell transplant in High Risk Hematologic Malignancies, sponsored by University of Utah. Terminated at 1 site in United States. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2020-08-11.
Sponsored by University of Utah · Phase 1, Interventional, and Treatment
Open label, dose finding trial to assess the efficacy of Treg/Tcon addback to partially matched related donor stem cells. The maximum tolerated dose will be established using 3 subjects per dose level, with an expansion cohort at the maximum tolerated dose.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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4b. Relapsed or primary refractory AML with \<10% blasts in the peripheral blood.
4c. Subjects in first complete remission (CR1) who required two cycles of induction to achieve remission may be included at the discretion of the treating physician.
4d. Standard risk or intermediate risk cytogenetics in second or subsequent CR (enrolled at the discretion of the treating physician).
9b. Subject with chemosensitive relapse who have no option for autologous stem cell transplantation due to blood or marrow involvement or failure to mobilize autologous stem cells or are not considered eligible for autologous transplant by their treating physician.
9c. Hodgkin's Lymphoma: relapse after autologous hematopoietic cell transplantation (HCT), chemo-refractory disease 9d. Multiple myeloma: per National Comprehensive Cancer Network (NCCN) guidelines. Updated annually at: www.nccn.org 10. No suitable human leukocyte antigen (HLA)-identical sibling donor. 11. No identified 8/8 (based upon A, B, C, DR beta 1 (DRB1) loci) allele matched unrelated donor, or unable to wait sufficient time to procure a 8/8 allele matched unrelated donor 12. Available HLA 3-5/6 matched genotypically haploidentical partially matched related donor 13. Female subjects must be surgically sterile, postmenopausal (minimum 1 year without menses), or agree to use approved form of contraception from the time of signing the informed consent form through Day +100. Male subjects must also agree to use an approved form of birth control for either themselves or their partner, as appropriate, from the time of signing the informed consent form through Day +100.
Exclusion Criteria:
Any of the following organ dysfunctions:
Biological: stem cell transplant · Procedure: Stem cell transplant
Open label, dose finding trial with two treatment regimens, Busulfan and Total Body Irradiation (TBI) with four dose escalation cohorts, to assess the efficacy of Treg/Tcon addback to partially matched related donor stem cells.
Rate of acute GVHD
Rate of acute Graft Versus Host Disease (GVHD) grade III-IV at Day +100 post transplant
Time frame: 36 months
Rate of Engraftment
Day +28 and +100 neutrophil engraftment
Time frame: 36 months
Survival at Day 100
Day +100 and one year survival Day +100 and one year transplant related mortality Day +100 and one year relapse rates
Time frame: 36 months
This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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University of Utah