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NCT04172844: PAVE
Pevonedistat, Azacitidine (or Decitabine), and Venetoclax for the Treatment of Patients With Acute Myelogenous Leukemia
Phase 1 trial testing Azacitidine in Acute Myelogenous Leukemia in 16 participants. Terminated before completion.
12 December 2021
Quick facts
| Lead sponsor | Medical College of Wisconsin |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 13 January 2020 |
| Primary completion | 12 December 2021 |
| Estimated completion | 27 February 2022 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Azacitidine (azacitidine) — full drug profile →
- Venetoclax (venetoclax) — full drug profile →
- Pevonedistat — full drug profile →
Conditions studied
- Acute Myelogenous Leukemia — all drugs for Acute Myelogenous Leukemia →
Sponsor
Medical College of Wisconsin
Who can join
18 and older, any sex, with Acute Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase Ib study with a 3 + 3 dose escalation design followed by a dose-expansion phase.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting NEDD8-activating enzyme for cancer therapy: developments, clinical trials, challenges and future research directions.
Fu DJ, Wang T. · · 2023 · cited 45× · PMID 37525282 · DOI 10.1186/s13045-023-01485-7 -
Transcription Factors: The Fulcrum Between Cell Development and Carcinogenesis.
Islam Z, Ali AM, Naik A, Eldaw M, et al · · 2021 · cited 38× · PMID 34195082 · DOI 10.3389/fonc.2021.681377 -
Targeting cullin neddylation for cancer and fibrotic diseases.
He ZX, Yang WG, Zengyangzong D, Gao G, et al · · 2023 · cited 33× · PMID 37771770 · DOI 10.7150/thno.78876 -
Deciphering the role of neddylation in tumor microenvironment modulation: common outcome of multiple signaling pathways.
Liu D, Che X, Wu G. · · 2024 · cited 25× · PMID 38191508 · DOI 10.1186/s40364-023-00545-x -
Venetoclax: A New Partner in the Novel Treatment Era for Acute Myeloid Leukemia and Myelodysplastic Syndrome.
El-Cheikh J, Bidaoui G, Saleh M, Moukalled N, et al · · 2023 · cited 22× · PMID 37071328 · DOI 10.1007/s44228-023-00041-x -
A phase I study of pevonedistat, azacitidine, and venetoclax in patients with relapsed/refractory acute myeloid leukemia.
Murthy GSG, Saliba AN, Szabo A, Harrington A, et al · · 2024 · cited 17× · PMID 38572562 · DOI 10.3324/haematol.2024.285014 -
Pevonedistat with azacitidine in older patients with TP53-mutated AML: a phase 2 study with laboratory correlates.
Saliba AN, Kaufmann SH, Stein EM, Patel PA, et al · · 2023 · cited 16× · PMID 36315007 · DOI 10.1182/bloodadvances.2022008625 -
Advances in therapeutic options for newly diagnosed, high-risk AML patients.
Doucette K, Karp J, Lai C. · · 2021 · cited 16× · PMID 33995985 · DOI 10.1177/20406207211001138
Verify or expand the search:
- PubMed search for NCT04172844
- 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 Myelogenous Leukemia
Currently open trials in the same condition.
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT06904482 — Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood · Phase 2 · recruiting
- NCT06680661 — ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis · Phase 2 · recruiting
- NCT06131801 — Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution · recruiting
- NCT05974150 — Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia · recruiting
Other Medical College of Wisconsin trials
Trials by the same sponsor.
- NCT07260552 — Rapid Engagement for Solutions to Population and Outcomes Through Networked Dialogue for Coronary Heart Disease · not yet recruiting
- NCT06795360 — Weight Changes After Incretin-mimetics · NA · not yet recruiting
- NCT07228208 — Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes · NA · not yet recruiting
- NCT07298460 — Stimulation-based Therapy to Improve Balance in DCM · Phase 1, PHASE2 · not yet recruiting
- NCT07434544 — Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D) · NA · not yet 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 NCT04172844 (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 Medical College of Wisconsin
- Last refreshed: 4 June 2024
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/NCT04172844.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing