Trials / Withdrawn
WithdrawnNCT03365661
QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Masonic Cancer Center, University of Minnesota · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase II multi-institutional therapeutic study of a non-myeloablative T cell receptor (TCR) alpha/beta depleted haploidentical transplantation with post-transplant immune reconstitution using ALT-803 for the treatment of high-risk myeloid leukemia (AML), treatment-related/secondary AML, and myelodysplastic syndrome (MDS).
Conditions
- High-Risk Acute Myeloid Leukemia
- Treatment-Related Acute Myeloid Leukemia
- Secondary Acute Myeloid Leukemia
- Myelodysplastic Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALT-803 | 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. |
Timeline
- Start date
- 2018-10-30
- Primary completion
- 2023-01-01
- Completion
- 2023-01-01
- First posted
- 2017-12-07
- Last updated
- 2018-11-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03365661. Inclusion in this directory is not an endorsement.