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NCT00101179
MS-275 and Azacitidine in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
Phase 1 trial testing Azacitidine in Acute Myeloid Leukemia in 63 participants. Completed in 3 February 2014.
20 April 2011
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 63 |
| Start date | 3 November 2004 |
| Primary completion | 20 April 2011 |
| Estimated completion | 3 February 2014 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Azacitidine (azacitidine) — full drug profile →
- Entinostat — full drug profile →
Conditions studied
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
- Chronic Myelomonocytic Leukemia — all drugs for Chronic Myelomonocytic Leukemia →
- de Novo Myelodysplastic Syndrome — all drugs for de Novo Myelodysplastic Syndrome →
- Leukemia — all drugs for Leukemia →
Sponsor
National Cancer Institute (NCI)
Who can join
18 and older, any sex, with Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving MS-275 together with azacitidine may kill more cancer cells. This phase I trial is studying the side effects and best dose of MS-275 when given together with azacitidine in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Early epigenetic changes and DNA damage do not predict clinical response in an overlapping schedule of 5-azacytidine and entinostat in patients with myeloid malignancies.
Fandy TE, Herman JG, Kerns P, Jiemjit A, et al · · 2009 · cited 218× · PMID 19546476 · DOI 10.1182/blood-2009-02-203547 -
Prolonged administration of azacitidine with or without entinostat for myelodysplastic syndrome and acute myeloid leukemia with myelodysplasia-related changes: results of the US Leukemia Intergroup trial E1905.
Prebet T, Sun Z, Figueroa ME, Ketterling R, et al · · 2014 · cited 188× · PMID 24663049 · DOI 10.1200/jco.2013.50.3102 -
Trials with 'epigenetic' drugs: an update.
Nebbioso A, Carafa V, Benedetti R, Altucci L. · · 2012 · cited 162× · PMID 23103179 · DOI 10.1016/j.molonc.2012.09.004 -
Recent advances in targeted therapies in acute myeloid leukemia.
Bhansali RS, Pratz KW, Lai C. · · 2023 · cited 151× · PMID 36966300 · DOI 10.1186/s13045-023-01424-6 -
Epigenetics-targeted drugs: current paradigms and future challenges.
Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0 -
Histone deacetylases in skeletal development and bone mass maintenance.
McGee-Lawrence ME, Westendorf JJ. · · 2011 · cited 80× · PMID 21185361 · DOI 10.1016/j.gene.2010.12.003 -
γ-H2AX and other histone post-translational modifications in the clinic.
Redon CE, Weyemi U, Parekh PR, Huang D, et al · · 2012 · cited 69× · PMID 22430255 · DOI 10.1016/j.bbagrm.2012.02.021 -
Azacitidine with or without Entinostat for the treatment of therapy-related myeloid neoplasm: further results of the E1905 North American Leukemia Intergroup study.
Prebet T, Sun Z, Ketterling RP, Zeidan A, et al · · 2016 · cited 64× · PMID 26577691 · DOI 10.1111/bjh.13832
Verify or expand the search:
- PubMed search for NCT00101179
- Europe PMC full search
- ASCO Meeting Library
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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 NCT00101179 (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 National Cancer Institute (NCI)
- Last refreshed: 18 October 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/NCT00101179.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing