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NCT04746235
Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia
Phase 2 trial testing Decitabine and Cedazuridine in Acute Myeloid Leukemia in 85 participants. Participants enrolled and being followed up; not accepting new ones.
31 October 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 85 |
| Start date | 22 February 2021 |
| Primary completion | 31 October 2026 |
| Estimated completion | 31 October 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Decitabine and Cedazuridine — full drug profile →
- Venetoclax (venetoclax) — full drug profile →
Conditions studied
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
- Recurrent Acute Myeloid Leukemia — all drugs for Recurrent Acute Myeloid Leukemia →
- Refractory Acute Myeloid Leukemia — all drugs for Refractory Acute Myeloid Leukemia →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Acute Myeloid Leukemia or Recurrent Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies the possible benefits of venetoclax and ASTX727 in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory), or elderly patients with newly diagnosed acute myeloid leukemia who are not candidates for intensive chemotherapy. Venetoclax may help block the formation of growths that may become cancer. ASTX727 is the combination of a fixed dose of 2 drugs, cedazuridine and decitabine. Cedazuridine may slow down how fast decitabine is broken down by the body, and decitabine may block abnormal cells or cancer cells from growing. Giving venetoclax and ASTX727 may help to control the disease.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Venetoclax resistance: mechanistic insights and future strategies.
Ong F, Kim K, Konopleva MY. · · 2022 · cited 79× · PMID 35800373 · DOI 10.20517/cdr.2021.125 -
Ten-day decitabine with venetoclax versus intensive chemotherapy in relapsed or refractory acute myeloid leukemia: A propensity score-matched analysis.
Maiti A, DiNardo CD, Qiao W, Kadia TM, et al · · 2021 · cited 33× · PMID 34343352 · DOI 10.1002/cncr.33814 -
Cedazuridine/decitabine: from preclinical to clinical development in myeloid malignancies.
Patel AA, Cahill K, Saygin C, Odenike O. · · 2021 · cited 29× · PMID 33904891 · DOI 10.1182/bloodadvances.2020002929 -
How We Incorporate Venetoclax in Treatment Regimens for Acute Myeloid Leukemia.
Maiti A, Konopleva MY. · · 2022 · cited 19× · PMID 35072368 · DOI 10.1097/ppo.0000000000000567 -
Oral decitabine and cedazuridine plus venetoclax for older or unfit patients with acute myeloid leukaemia: a phase 2 study.
Bazinet A, Garcia-Manero G, Short N, Alvarado Y, et al · · 2024 · cited 16× · PMID 38452788 · DOI 10.1016/s2352-3026(24)00033-4 -
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 -
Clinical activity, pharmacokinetics, and pharmacodynamics of oral hypomethylating agents for myelodysplastic syndromes/neoplasms and acute myeloid leukemia: A multidisciplinary review.
Haumschild R, Kennerly-Shah J, Barbarotta L, Zeidan AM. · · 2024 · cited 12× · PMID 38509812 · DOI 10.1177/10781552241238979 -
Combination of a New Oral Demethylating Agent, OR2100, and Venetoclax for Treatment of Acute Myeloid Leukemia.
Kamachi K, Ureshino H, Watanabe T, Yoshida-Sakai N, et al · · 2023 · cited 12× · PMID 36860654 · DOI 10.1158/2767-9764.crc-22-0259
Verify or expand the search:
- PubMed search for NCT04746235
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Decitabine and Cedazuridine
Trials testing the same drug.
- NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
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- NCT07153497 — Testing the Use of an IDH1 Inhibitor, Olutasidenib, in Acute Myeloid Leukemia Added to ASTX727 and Venetoclax; in High-R · Phase 2 · not yet recruiting
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Other recruiting trials for Acute Myeloid Leukemia
Currently open trials in the same condition.
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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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 NCT04746235 (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 M.D. Anderson Cancer Center
- Last refreshed: 12 March 2026
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/NCT04746235.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing