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NCT03699384
Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)
Phase 1, PHASE2 trial testing Azacitidine in Acute Myeloid Leukemia (AML). Withdrawn.
18 February 2019
Quick facts
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 3 October 2018 |
| Primary completion | 18 February 2019 |
| Estimated completion | 18 February 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Azacitidine (azacitidine) — full drug profile →
- Avelumab (avelumab) — full drug profile →
Conditions studied
- Acute Myeloid Leukemia (AML) — all drugs for Acute Myeloid Leukemia (AML) →
- Minimal Residual Disease — all drugs for Minimal Residual Disease →
Sponsor
Memorial Sloan Kettering Cancer Center — full company profile →
Who can join
18 and older, any sex, with Acute Myeloid Leukemia (AML) or Minimal Residual Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase I / II study. The purposes of this study are to: 1) find out what effects, good and/or bad, the combination of the experimental drug avelumab and the drug azacitidine has on people with AML and MRD, and 2) test if the two drugs, avelumab and azacitidine, are effective in getting rid of AML MRD when the drugs are given together in combination.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Chemokines Modulate Immune Surveillance in Tumorigenesis, Metastasis, and Response to Immunotherapy.
Vilgelm AE, Richmond A. · · 2019 · cited 310× · PMID 30873179 · DOI 10.3389/fimmu.2019.00333 -
MRD Tailored Therapy in AML: What We Have Learned So Far.
Ngai LL, Kelder A, Janssen JJWM, Ossenkoppele GJ, et al · · 2020 · cited 37× · PMID 33575214 · DOI 10.3389/fonc.2020.603636 -
Measurable Residual Disease (MRD) as a Surrogate Efficacy-Response Biomarker in AML.
Meddi E, Savi A, Moretti F, Mallegni F, et al · · 2023 · cited 12× · PMID 36834477 · DOI 10.3390/ijms24043062
Verify or expand the search:
- PubMed search for NCT03699384
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Azacitidine
Trials testing the same drug.
- 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 Myeloid Leukemia (AML)
Currently open trials in the same condition.
- NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
- NCT07500441 — Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML · recruiting
- NCT07410494 — Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06707493 — Ivosidenib as Post-HSCT Maintenance for AML · Phase 2 · recruiting
- NCT07458542 — Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia · active not recruiting
Other Memorial Sloan Kettering Cancer Center trials
Trials by the same sponsor.
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
- NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
- NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
- NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03699384 (US National Library of Medicine, public domain)
- 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 Memorial Sloan Kettering Cancer Center
- Last refreshed: 20 February 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/NCT03699384.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing