Trial · NCT01385423
Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML)
NCT01385423, Phase 1, Completed, Masonic Cancer Center, University of Minnesota
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML). Trials, record NCT01385423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01385423
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML)
- NCT number
- NCT01385423
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Acute Myelogenous Leukemia, Myelodysplastic Syndrome
- Interventions
- Preparative Regimen, Intravenous Recombinant Human IL-15 (rhIL-15)
- First posted
- 2011-06-30
- Last updated
- 2025-07-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated/Minimum Efficacious Dose | Day 42 | Determine the maximum tolerated, minimum efficacious dose (MTD/MED) of recombinant human IL-15; dose limiting toxicity (DLT) occurring during the first 42 days after the NK cell infusion; MED = if 2 of 3 patients or 4 of 6 patients has an in vivo NK cell count \>2500, then dose escalation with cease as it will be in the range of a biologic dose which may achieve the goal of in vivo expansion without pushing IL-15 doses higher to toxicity. |
| Secondary | Incidence of Expansion of Natural Killer Cells | Day 14 after Infusion | defined by measuring an absolute circulating donor-derived NK cell count of \>100 cells/μl in the patient's peripheral blood by day +14 after the NK cell infusion. |
| Secondary | Treatment Related Mortality (TRM) | Day 1 of Treatment until Day of Death | In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation. |
| Secondary | Rate of CRp | Day 28-42 | defined as leukemia clearance (\< 5% marrow blasts and no peripheral blood blasts) and neutrophil recovery without platelet recovery. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31266741 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01385423
GET https://conductscience.org/api/trials/v1/NCT01385423/registered