Clinical trial · Observational
Decitabine for Chemotherapy Unfit Korean AML Patients in Real Practice
Prospective Observation of the indUction Regimen for Acute Non-Promyelocytic Myeloid Leukemia in Elderly; Decitabine for Chemotherapy Unfit Korean Acute Myeloid Leukemia (AML) Patients in Real Practice
NCT02698124CI-TRIAL-00021243PURPLE-DunknownClinicalTrials.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)
Prospective multicenter, open-lab el, observational, single arm study of decitabine. Subjects will be elderly patients with newly diagnosed, treatment-naïve AML who are unfit to receive and not candidate for intensive induction chemotherapy (iIC)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Elderly | — | UNRESOLVED | — |
| Intensive Chemotherapy Unfit | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Decitabine
- description
- Decitabine 20mg/m2 will be given IV daily on Days 1-5 in 28-day cycles. Treatment should be given for at least 4 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Beyond 4 cycles, treatment should continue as long as the subject continues to benefit based on investigator's judgment of no definitive progression.
- interventionNames
- Drug: Decitabine
Primary outcomes (1)
- measure
- The rate of complete remission
- timeFrame
- after 4 cycles of decitabine treatment (about 4 months)
- description
- The rate of complete remission and complete remission with incomplete platelet recovery (CRp) will be measured by 4 cycles of decitabine treatment.
Secondary outcomes (5)
- measure
- The rate of composite CR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed and therapy-naïve AML (bone marrow or peripheral blood blast counts ≥20%) 2. 65 years of age or older 3. Taking informed consent with signature and date 4. Not eligible for iIC based on either: i) ≥75 years of age ii) comorbidity iii) secondary AML iv) poor performance (ECOG ≥2) v) Poor-risk by NCCN Guideline version 1.2015 vi) subject's choice (refusal for iIC) investigator's judgement incompatible with iIC Exclusion Criteria: 1. Candidate for iIC at the time of enrollment 2. Promyelocytic leukemia, or AML with t(15;17) or PML/RARα rearrangement 3. AML with t(9;22) or BCR/ABL rearrangement 4. Leukemia central nervous system involvement 5. Extramedullary myeloid sarcoma without bone marrow involvement 6. Prior treatment with decitabine or azacitidine of any cause 7. Any leukemia-specific therapy, except for hydroxyurea for reducing leukemic cells prior decitabine 8. Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy, or curatively resected non-melanoma skin cancer or intraepithelial cancer 9. Premenopausal woman 10. Severe active infection 11. Uncontrolled bleeding Hypersensitivity to decitabine
References
Publications (7)
- RESULTKantarjian HM, Thomas XG, Dmoszynska A, Wierzbowska A, Mazur G, Mayer J, Gau JP, Chou WC, Buckstein R, Cermak J, Kuo CY, Oriol A, Ravandi F, Faderl S, Delaunay J, Lysak D, Minden M, Arthur C. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia. J Clin Oncol. 2012 Jul 20;30(21):2670-7. doi: 10.1200/JCO.2011.38.9429. Epub 2012 Jun 11. PMID 22689805
- RESULTBlum W, Garzon R, Klisovic RB, Schwind S, Walker A, Geyer S, Liu S, Havelange V, Becker H, Schaaf L, Mickle J, Devine H, Kefauver C, Devine SM, Chan KK, Heerema NA, Bloomfield CD, Grever MR, Byrd JC, Villalona-Calero M, Croce CM, Marcucci G. Clinical response and miR-29b predictive significance in older AML patients treated with a 10-day schedule of decitabine. Proc Natl Acad Sci U S A. 2010 Apr 20;107(16):7473-8. doi: 10.1073/pnas.1002650107. Epub 2010 Apr 5. PMID 20368434
- RESULTMims A, Walker AR, Huang X, Sun J, Wang H, Santhanam R, Dorrance AM, Walker C, Hoellerbauer P, Tarighat SS, Chan KK, Klisovic RB, Perrotti D, Caligiuri MA, Byrd JC, Chen CS, James Lee L, Jacob S, Mrozek K, Bloomfield CD, Blum W, Garzon R, Schwind S, Marcucci G. Increased anti-leukemic activity of decitabine via AR-42-induced upregulation of miR-29b: a novel epigenetic-targeting approach in acute myeloid leukemia. Leukemia. 2013 Apr;27(4):871-8. doi: 10.1038/leu.2012.342. Epub 2012 Nov 26. PMID 23178755
- RESULTSuzuki H, Maruyama R, Yamamoto E, Kai M. DNA methylation and microRNA dysregulation in cancer. Mol Oncol. 2012 Dec;6(6):567-78. doi: 10.1016/j.molonc.2012.07.007. Epub 2012 Aug 10. PMID 22902148
- RESULTKim Y, Cheong JW, Kim YK, Eom JI, Jeung HK, Kim SJ, Hwang D, Kim JS, Kim HJ, Min YH. Serum microRNA-21 as a potential biomarker for response to hypomethylating agents in myelodysplastic syndromes. PLoS One. 2014 Feb 4;9(2):e86933. doi: 10.1371/journal.pone.0086933. eCollection 2014. PMID 24503739