Clinical trial · Interventional
Aza With or Without ATRA in Newly Diagnosed Unfit AML or Intermediate,High or Very High Risk MDS
Azacitidine in Combination With or Without All-trans Retinoic Acid in Newly Diagnosed Unfit Acute Myeloid Leukemia or Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria
NCT05175508CI-TRIAL-00055754unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized, open-label, multicenter study to compare the efficacy and safety of AZA with or without ATRA in newly diagnosed unfit AML or Intermediate,High or Very High Risk MDS
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hematologic Cancer | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| MDS | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Old Age; Debility | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| all trans retinoic acid | Drug | Tretinoin | ALIAS |
| Azacitidine | Drug | Azacitidine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Azacytidine Combined With ARTA
- description
- Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle with ATRA 20mg tid by po on days 1-21 of every cycle 28 days
- interventionNames
- Drug: Azacitidine
- Drug: all trans retinoic acid
- type
- EXPERIMENTAL
- label
- Azacytidine
- description
- Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle
- interventionNames
- Drug: Azacitidine
Primary outcomes (3)
- measure
- Overall Response Rate （ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (2017 edition)，excludes acute promyelocytic leukemia (M3、APL) and myelodysplastic syndromes(2017 edition) * Be at least 18 years of age on day of signing informed consent * Not suitable for newly diagnosed patients with intensive chemotherapy * Not suitable for newly diagnosed patients with receiving hematopoietic stem cell transplantation * The proportion of blast cells was below 50% in bone marrow * Total white blood cell (WBC) count ≤10,000/µL；Must be able to swallow tablets Exclusion Criteria: * Malignant neoplasms with other progression * Serious mental illness uncooperative * Refusal to join the study
References
Publications (11)
- BACKGROUNDChinese Society of Hematology, Chinese Medical Association. [Chinese guidelines for diagnosis and treatment of myelodysplastic syndromes (2019)]. Zhonghua Xue Ye Xue Za Zhi. 2019 Feb 14;40(2):89-97. doi: 10.3760/cma.j.issn.0253-2727.2019.02.001. No abstract available. Chinese. PMID 30831622
- BACKGROUNDLeukemia & Lymphoma Group, Chinese Society of Hematology, Chinese Medical Association. [Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia (not APL) (2017)]. Zhonghua Xue Ye Xue Za Zhi. 2017 Mar 14;38(3):177-182. doi: 10.3760/cma.j.issn.0253-2727.2017.03.001. No abstract available. Chinese. PMID 28395438
- BACKGROUNDDombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Recher C, Sandhu I, Bernal del Castillo T, Al-Ali HK, Martinelli G, Falantes J, Noppeney R, Stone RM, Minden MD, McIntyre H, Songer S, Lucy LM, Beach CL, Dohner H. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18. PMID 25987659
- BACKGROUNDDelia M, Carluccio P, Buquicchio C, Vergine C, Greco G, Amurri B, Melpignano A, Melillo L, Cascavilla N, Guarini A, Capalbo S, Tarantini G, Mazza P, Pavone V, Di Renzo N, Specchia G. Azacitidine in the treatment of older patients affected by acute myeloid leukemia: A report by the Rete Ematologica Pugliese (REP). Leuk Res. 2015 Aug 20:S0145-2126(15)30358-1. doi: 10.1016/j.leukres.2015.08.005. Online ahead of print. PMID 26364798
- BACKGROUNDFenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Finelli C, Giagounidis A, Schoch R, Gattermann N, Sanz G, List A, Gore SD, Seymour JF, Bennett JM, Byrd J, Backstrom J, Zimmerman L, McKenzie D, Beach C, Silverman LR; International Vidaza High-Risk MDS Survival Study Group. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009 Mar;10(3):223-32. doi: 10.1016/S1470-2045(09)70003-8. Epub 2009 Feb 21.