A Phase 2 interventional study of Graft cell infusion and Tacrolimus in Acute Myeloid Leukemia, sponsored by Washington University School of Medicine. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment
This is a standard phase 2 study powered to demonstrate improvement in the 100 day leukemia free survival to 30% from \<10% expected with the use of reduced intensity haplo-HCT in this extremely high-risk patient cohort (based on the institutional experience using non-myeloablative / reduced intensity conditioning in a similar patient cohort).
A formal safety evaluation will be done after every 6th patient enrolled and the trial will be stopped if noted to have unusually higher engraftment failure (acute GVHD rates (>60% any grades or >30% grade III/IV or ≥ 50% severe cGVHD) or engraftment failure rates (≥15%).
2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.
This study's enrollment of 60 is above the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Recipient Inclusion Criteria:
Adequate organ function as defined below:
Recipient Exclusion Criteria:
Donor Inclusion Criteria:
Donor Exclusion Criteria:
* Standard of care reduced conditioning regimen on Day -1 * Graft cell infusion on Day 0 * Post-transplant cyclophosphamide on Days +3 and +4 * GvHD prophylaxis with tacrolimus and mycophenolate mofetil (MMF) will start on Day +5. MMF will continue till Day +35 and tacrolimus till Day +180 in the absence of GvHD * G-CSF will start on Day +7 and will continue until neutrophil engraftment as per institutional guidelines * The cytokine-induced memory like natural killer (CIML NK) cells will be infused on Day +7 without a filter or pump, slowly by gravity over at least 15 minutes. * ALT-803 will start approximately 4 hours after the CIML NK cell infusion. ALT-803 will be administered subcutaneously at a dose of 10 mcg/kg subcutaneously beginning Day +7 (on the day of CIML NK cell infusion) and then every 21 days for a total of 4 doses
Procedure: Graft cell infusion · Drug: Tacrolimus · Drug: Mycophenolate mofetil · Drug: G-CSF · Procedure: CIML NK cell infusion · Drug: ALT-803
* Donors will receive subcutaneous G-CSF from Day -4 till Day 0 and undergo 20L apheresis per institutional guidelines. * Two consecutive days for collection are allowed in case of the target CD34+ cell dose being less than the target 4 x106/kg-bw from the first day of collection. * On Day +6 (one day before the planned CIML NK cell infusion), peripheral blood mononuclear cells will be collected by a single standard 20-L apheresis over 4-5 hours from the same haploidentical related donor that provided the HCT graft.
Procedure: Leukapheresis
-Day 0
Also known as: HCT
-GVHD prophylaxis
Also known as: Prograf
-GVHD prophylaxis
Also known as: CellCept, Myfortic
-Continue until neutrophil engraftment as per institutional guidelines
Also known as: Granulocyte-colony stimulating factor
-Day +7
-Start approximately 4 hours after CIML NK cell infusion
-Day +6
Kaplan-Meier Estimate of Leukemia-free Survival Rate (LFS)
-LFS is defined as the time from achievement of complete remission (CR) to the time of relapse, death in remission, or last follow-up.
Time frame: 1 year post transplantation
Kaplan-Meier Estimate of Leukemia-free Survival Rate (LFS)
-LFS is defined as the time from achievement of CR to the time of relapse, death in remission, or last follow-up.
Time frame: 3 months post transplantation
Kaplan-Meier Estimate of Overall Survival (OS)
-OS is defined as the time from the date of Day 0 until death from any cause.
Time frame: 1 year post transplantation
Number of Recipients With Relapse Who Are Found to be CR (Complete Remission)
-CR: Morphologically leukemia free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions.
Time frame: Day 28 post transplantation
Complete Remission (CR) Rate
CR: Morphologically leukemia free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions
Time frame: Day 28 post transplantation
| Milestone | Recipient | Donor |
|---|---|---|
| Started | 30 | 30 |
| Completed | 29 | 29 |
| Not completed | 1 | 1 |
| Withdrew: Did not collect enough nk cells from donor | 1 | 0 |
| Withdrew: Did not produce enough nk cells | 0 | 1 |
-LFS is defined as the time from achievement of complete remission (CR) to the time of relapse, death in remission, or last follow-up.
| percentage of participants-Kaplan Meier | Recipient |
|---|---|
| Kaplan-Meier Estimate of Leukemia-free Survival Rate (LFS) | 16.67 (5.93 to 46.82) |
-LFS is defined as the time from achievement of CR to the time of relapse, death in remission, or last follow-up.
| percentage of participants-Kaplan Meier | Recipient |
|---|---|
| Kaplan-Meier Estimate of Leukemia-free Survival Rate (LFS) | 61.11 (42.27 to 88.34) |
-OS is defined as the time from the date of Day 0 until death from any cause.
| percentage of participants-Kaplan Meier | Recipient |
|---|---|
| Kaplan-Meier Estimate of Overall Survival (OS) | 31.034 (18.04 to 53.39) |
-CR: Morphologically leukemia free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions.
| Participants | Recipient |
|---|---|
| Number of Recipients With Relapse Who Are Found to be CR (Complete Remission) | 8 |
CR: Morphologically leukemia free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions
| Participants | Recipient |
|---|---|
| Complete Remission (CR) Rate | 13 |
Collected over - Adverse events for recipients were collected from the CIML NK cell infusion until 100 days after CIML NK cell infusion and 30 days after last injection of ALT-803. Adverse events of interest were collected until the last scheduled subject contact at 48 months after the last injection of ALT-803. - All cause mortality was collected from the start of treatment through completion of follow-up (up to 48 months) -Adverse events were not collected on donors. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Recipient | 27/29 (93.1%) | 10/29 (34.5%) | 29/29 (100%) |
| Donor | — | — | — |
| Event | Recipient | Donor |
|---|---|---|
| DiarrheaGastrointestinal disorders | 4/29 | — |
| SepsisInfections and infestations | 3/29 | — |
| Death due to disease progressionGeneral disorders | 2/29 | — |
| FeverGeneral disorders | 2/29 | — |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/29 | — |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 2/29 | — |
| Pericardial effusionCardiac disorders | 1/29 | — |
| Abdominal painGastrointestinal disorders | 1/29 | — |
| Multi-organ failureGeneral disorders | 1/29 | — |
| Bacteremia - VREInfections and infestations | 1/29 | — |
| Event | Recipient | Donor |
|---|---|---|
| HyponatremiaMetabolism and nutrition disorders | 21/29 | — |
| VomitingGastrointestinal disorders | 19/29 | — |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 19/29 | — |
| NauseaGastrointestinal disorders | 18/29 | — |
| FatigueGeneral disorders | 16/29 | — |
| Aspartate aminotransferase increasedInvestigations | 16/29 | — |
| Alanine aminotransferase increasedInvestigations | 15/29 | — |
| HypomagnesemiaMetabolism and nutrition disorders | 15/29 | — |
| TremorNervous system disorders | 14/29 | — |
| Injection site reactionGeneral disorders | 13/29 | — |
| Age, Continuous(years) | Recipient | Donor | Total |
|---|---|---|---|
| Mean | 57 (19 to 73) | 39.9 (19 to 68) | 48.5 (19 to 73) |
| Sex: Female, Male(Participants) | Recipient | Donor | Total |
|---|---|---|---|
| Female | 13 | 16 | 29 |
| Male | 17 | 14 | 31 |
| Ethnicity (NIH/OMB)(Participants) | Recipient | Donor | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 30 | 27 | 57 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Recipient | Donor | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 28 | 27 | 55 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Recipient | Donor | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
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Washington University School of Medicine