18 and older, any sex, with Acute Biphenotypic Leukemia or Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose of Iirilumab in Combination With 5-azacitidinePrimary· Up to 28 days
To identify the dose at which \<2/6 participants experience Dose Limiting Toxicities (DLT). The dose level at which 0-1/6 participants experience a DLT in the first 28 days of treatment will be the maximum tolerated dose (MTD) and would be used to treat an additional 34 participants in the phase II potion of the study. (Part A, Lead-In Phase)
Group
Value
95% CI
All Phase 1 Participants
3.0
Participants With an Objective ResponsePrimary· Up to 3 months
Objective Response Rate (ORR) will be monitored using the Bayesian approach of Thall, Simon, Estey and the extension by Thall and Sung. Overall response rate (ORR), defined as complete remission (CR) + CR with incomplete platelet recovery (CRp) + CR with incomplete count recovery (CRi) + partial response (PR) + marrow clearance of blasts + hematological improvement within 3 months of treatment initiation among adult patients with refractory/relapsed Acute Myelogenous Leukemia (AML) (Phase II)
Group
Value
95% CI
Phase 1b Lead-in Cohort 1
2
Phase 1b Lead-in Cohort 2
1
Phase 2
2
Duration of ResponseSecondary· Up to 2.5 years
The date of Objective Response to the date of loss of response or last follow-up.
Group
Value
95% CI
Phase 2
7.7
2.0 – 17.0
Overall SurvivalSecondary· Up to 2 years
Overall Survival (OS) is defined: Time of presentation to date of death or censored at last follow-up date.
Group
Value
95% CI
Phase 2
3.5
0.4 – 22.2
Disease Free SurvivalSecondary· Up to 2.5 years
Disease Free Survival (DFS) is defined: Time from date of treatment start until the date of first objective documentation of disease-relapse
Group
Value
95% CI
Phase 2
7.7
2.0 – 17.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to two and a half years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies the side effects lirilumab and azacitidine and to see how well they work in treating patients with acute myeloid leukemia that has not responded to treatment or has returned after a period of improvement. Monoclonal antibodies, such as lirilumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving lirilumab with azacitidine may be an effective treatment for relapsed or refractory acute myeloid leukemia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07508982 — Phase1b/2 Trial Of AZA + APG1252 In Patients With High-Risk AML
· Phase 1, PHASE2
· not yet recruiting
NCT05554419 — Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Tr
· Phase 2
· not yet recruiting
NCT07490288 — Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML
· NA
· not yet recruiting
NCT07469046 — VAH vs VA in Newly Diagnosed Elderly AML
· Phase 3
· not yet recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I
· Phase 2
· recruiting
Other recruiting trials for Acute Biphenotypic Leukemia
Currently open trials in the same condition.
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· Phase 2
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NCT04797767 — Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
· Phase 1, PHASE2
· recruiting
NCT04128501 — Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting
· Phase 2
· active not recruiting
NCT03779854 — Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers
· Phase 2
· recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem
· Phase 1, PHASE2
· not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and
· Phase 1
· not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che
· Phase 2
· not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca
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NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 24 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02399917.