QUILT-3.035: Relapse Prophylaxis With ALT-803 for AML and MDS Pts Following Allo HSCT
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|ClinicalTrials.gov Identifier: NCT02989844|
Recruitment Status : Suspended (Pending Amendment)
First Posted : December 12, 2016
Last Update Posted : October 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia (AML) Myelodysplastic Syndrome (MDS)||Drug: ALT-803||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||QUILT-3.035: Relapse Prophylaxis With IL-15 Super Agonist ALT-803 in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome Following Allogeneic Stem Cell Transplantation|
|Actual Study Start Date :||April 12, 2017|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
ALT-803 6 mcg/kg will be administered subcutaneously once a week on day 1, 8, 15 and 22 followed by 4 weeks of no treatment. Up to 4 treatment cycles (4 weeks on/4 weeks off) are permitted.
- Incidence of Relapse [ Time Frame: 12 months ]Efficacy of ALT-803 as measured by the cumulative incidence of relapse between the 1st dose of ALT-803 (approximately day 70) and 12 months after a reduced intensity conditioning (RIC) allogeneic hematopoietic cell transplant (alloHCT)
- Incidence of Adverse Events [ Time Frame: 12 months ]Frequency of adverse and serious adverse events
- Incidence of acute graft-versus-host disease [ Time Frame: Day 100 ]Incidence of grade 2-4 and grade 3-4 acute graft-versus-host-disease (GVHD)
- Incidence of acute graft-versus-host disease [ Time Frame: Day 180 ]Incidence of grade 2-4 and grade 3-4 acute graft-versus-host-disease (GVHD)
- Chronic GVHD [ Time Frame: 1 year ]Incidence of acute graft-versus-host disease
- Minimal residual disease (MRD) [ Time Frame: day 100, 1 year ]Incidence of minimal residual disease (MRD) post-transplant.
- Overall survival [ Time Frame: 1 year post transplant ]Incidence of overall survival at one year.
- Non-Relapse mortality [ Time Frame: 1 year ]Incidence of non-relapse mortality
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): NCT02989844
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Celalettin Ustun, MD||University of Minnesota - Clinical and Translational Science Institute|