18 and older, any sex, with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome or Recurrent Acute Myeloid Leukemia. 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.
Number of Participants With a ResponsePrimary· Up to 2 years
Complete Response (CR) + Partial Remission (PR) + Complete Remission with incomplete recovery (CRi) + Clinical Benefit. CR = normalization of peripheral blood (PB) and bone marrow (BM) with \</= 5% BM blasts, PB granulocyte count \>/= (1.0 x 10\^9/L, and a platelet count \>/= 100 x 10\^9/L). PR = same as CR except presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. CRi meets all criteria for CR except for platelet recovery to \>100 x 10\^9/L and/or granulocyte count \> (1.0 x 10\^9/L). MLFS is BM with \</= 5% BM blasts with no PB recovery. Hematologic Improvement
Group
Value
95% CI
Treatment (Azacitidine, Avelumab)
4
Disease-free SurvivalSecondary· Up to 1 year
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Group
Value
95% CI
Treatment (Azacitidine, Avelumab)
8.2
6.5 – 9.8
Overall Survival (OS)Secondary· Up to 1 year
Distribution of OS will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests.
Group
Value
95% CI
Treatment (Azacitidine, Avelumab)
4.7
0.1 – 11.0
Progression Free Survival (PFS)Secondary· Up to 1 year
Distribution of PFS will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests.
Group
Value
95% CI
Treatment (Azacitidine, Avelumab)
3.2
0.1 – 10.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase Ib/II trial studies the best dose and side effects of avelumab when given together with azacitidine and to see how well they work in treating patients with acute myeloid leukemia that is not responding to treatment or has come back. Monoclonal antibodies, such as avelumab, may interfere with the ability of cancer cells to grow and spread. Azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving avelumab and azacitidine may work better in treating patients with acute myeloid leukemia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06939036 — Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )
· Phase 1, PHASE2
· terminated
NCT05687721 — Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer
· Phase 1, PHASE2
· withdrawn
NCT06518564 — Avelumab and M1774 in ARID1A-mutated Endometrial Cancer
· Phase 2
· recruiting
NCT06424717 — Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L
· Phase 2
· withdrawn
NCT06302426 — Trial of INI-4001 in Patients With Advanced Solid Tumours
· Phase 1
· recruiting
Other recruiting trials for Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Currently open trials in the same condition.
NCT04269213 — CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old
· Phase 2
· active not recruiting
NCT04214249 — BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leuke
· Phase 2
· active not recruiting
NCT04284787 — BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leuke
· Phase 2
· active not recruiting
NCT04190550 — Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patient
· Phase 1
· active not recruiting
NCT03953898 — Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With
· Phase 2
· active not 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
· Phase 2
· not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar
· Phase 1
· not yet recruiting
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: 22 October 2020
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/NCT02953561.