QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML
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|ClinicalTrials.gov Identifier: NCT03365661|
Recruitment Status : Withdrawn (Sponsor halted study.)
First Posted : December 7, 2017
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|High-Risk Acute Myeloid Leukemia Treatment-Related Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia Myelodysplastic Syndrome||Biological: ALT-803||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||QUILT-3.034: Multi-Center Trial of Non-Myeloablative TCRa/b Deplete Haploidentical Hematopoietic Cell Transplantation With Post HCT ALT-803 in High-Risk Myeloid Diseases|
|Estimated Study Start Date :||October 30, 2018|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
A reduced intensity conditioning starts on Day -6, (CY/FLU/TBI/TLI) followed by infusion of a TCRα/β-deplete haploidentical graft on Day 0. Two doses of ALT-803 are given initially (early) 1 week apart to facilitate NK cell expansion. ALT-803 maintenance (late) for immune reconstitution begins at Day 42 and consists of 4 weekly doses, followed by 4 weeks off. Up to four 8 week treatment courses are permitted. No post-transplant GVHD prophylaxis is administered unless the final donor cell product contains > 2 x 105 α/β T cells/kg recipient weight.
- Incidence of disease response [ Time Frame: Day 28 ]Rate of donor neutrophil engraftment in the absence of disease at Day +28. Neutrophil engraftment is defined as absolute neutrophil count (ANC) ≥ 5 X 10 8 /L.
- Disease Free Survival (DFS) [ Time Frame: 12 months ]Incidence of disease free survival (DFS).
- Treatment Related Mortality (TRM) [ Time Frame: 12 months ]Incidence of treatment related mortality (TRM).
- Disease Relapse [ Time Frame: 12 months ]Incidence of disease relapse.
- Grade II-IV acute Graft versus Host Disease (aGVHD) [ Time Frame: Day 100 ]Incidence of acute Graft versus Host Disease measured by the number of T-cells infused or NK cells engrafted causing GVHD syndrome.
- Serious Adverse Events from ALT-803 (Early Schedule) [ Time Frame: 1 Year ]Incidence of serious adverse events from ALT-803 will be measured for an initial 2 doses, given one week apart.
- Serious Adverse Events from ALT-803 (Late Schedule) [ Time Frame: 1 Year ]Incidence of serious adverse events from ALT-803 will be measured for 16 doses, given over 4 weeks.
- Chronic Graft versus Host Disease (cGVHD) [ Time Frame: 1 year ]Incidence of chronic Graft versus Host Disease will be measured by the number of T-cells infused or NK cells engrafted causing GVHD syndrome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365661
|United States, Minnesota|
|Masonic Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Sarah Cooley, MD||University of Minnesota|