Last reviewed · How we verify
NCT03330821
Pevonedistat, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia
Phase 1, PHASE2 trial testing Cytarabine in Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome in 53 participants. Participants enrolled and being followed up; not accepting new ones.
30 June 2026
Quick facts
| Lead sponsor | University of Southern California |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 18 April 2018 |
| Primary completion | 30 June 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Cytarabine — full drug profile →
- Idarubicin (IDARUBICIN) — full drug profile →
- Laboratory Biomarker Analysis
- Pevonedistat — full drug profile →
- Pharmacological Study — full drug profile →
Conditions studied
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome — all drugs for Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome →
- Acute Myeloid Leukemia With Myelodysplasia-Related Changes — all drugs for Acute Myeloid Leukemia With Myelodysplasia-Related Changes →
- Therapy-Related Acute Myeloid Leukemia — all drugs for Therapy-Related Acute Myeloid Leukemia →
Sponsor
University of Southern California
Who can join
18 and older, any sex, with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome or Acute Myeloid Leukemia With Myelodysplasia-Related Changes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase Ib/II trial studies the side effects and best dose of pevonedistat and to see how well it works in combination with cytarabine and idarubicin in treating patients with acute myeloid leukemia. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and idarubicin, 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. Given pevonedistat, cytarabine, and idarubicin may work better in treating patients with acute myeloid leukemia.
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 -
AML with Myelodysplasia-Related Changes: Development, Challenges, and Treatment Advances.
Koenig KL, Sahasrabudhe KD, Sigmund AM, Bhatnagar B. · · 2020 · cited 42× · PMID 32722092 · DOI 10.3390/genes11080845 -
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 -
Harnessing DNA Replication Stress for Novel Cancer Therapy.
Zhu H, Swami U, Preet R, Zhang J. · · 2020 · cited 30× · PMID 32854236 · DOI 10.3390/genes11090990 -
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 -
Targeting Apoptosis in AML: Where Do We Stand?
Krawiec K, Strzałka P, Czemerska M, Wiśnik A, et al · · 2022 · cited 14× · PMID 36291779 · DOI 10.3390/cancers14204995 -
The Double-Edged Effects of MLN4924: Rethinking Anti-Cancer Drugs Targeting the Neddylation Pathway.
Tang H, Pang X, Li S, Tang L. · · 2024 · cited 11× · PMID 39062453 · DOI 10.3390/biom14070738
Verify or expand the search:
- PubMed search for NCT03330821
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cytarabine
Trials testing the same drug.
- 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
- NCT07498465 — A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant · Phase 1 · withdrawn
- NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) · Phase 1 · not yet recruiting
- NCT07428486 — A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractor · Phase 1 · not yet recruiting
- NCT07022678 — Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia · Phase 3 · not yet 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 University of Southern California trials
Trials by the same sponsor.
- NCT07288463 — Hearing Loss and Genetic Risks for Alzheimer's Disease and Related Dementia · NA · not yet recruiting
- NCT05914233 — Non-invasive Ultrasound Retinal Stimulation for Vision Restoration · NA · not yet recruiting
- NCT06163664 — Role of ChatGPT in Vestibular Schwannoma Management · NA · withdrawn
- NCT07332312 — A Culturally Informed Patient Navigation Program (CFPN) to Reduce Delays Between Diagnosis and Treatment in American Ind · NA · not yet recruiting
- NCT07290478 — Encouraging Older Adults and Adults With Serious Illness to Designate a Health Care Proxy · 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 NCT03330821 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 University of Southern California
- Last refreshed: 4 December 2025
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/NCT03330821.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing