Clinical trial · Interventional
Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML)
A Randomized Phase II Study of Two Schedules of Decitabine for Frontline Therapy of Older or Unfit Patients With Acute Myeloid Leukemia (AML)
NCT01786343CI-TRIAL-00044670completedPhase 2Results postedClinicalTrials.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)
The goal of this clinical research study is to compare how well 2 different dosing schedules of decitabine may help control AML. Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Decitabine - 5 Day Regimen
- description
- Decitabine 20 mg/m2 by vein daily for 5 days.
- interventionNames
- Drug: Decitabine
- type
- EXPERIMENTAL
- label
- Decitabine - 10 Day Regimen
- description
- Decitabine 20 mg/m2 by vein daily for 10 days.
- interventionNames
- Drug: Decitabine
Primary outcomes (1)
- measure
- Participants With a Response
- timeFrame
- Up to 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with previously untreated AML (by the World Health Organization (WHO) criteria, i.e. \>/= 20% blasts) Prior biologic therapies (such as growth factors) and targeted therapies administered for the treatment of prior myelodysplastic syndrome are allowed, with the exception of hypomethylating agents 5-azacytidine or decitabine. Patients must have been off such therapy for 1 week prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. Hydroxyurea, and a single dose of cytarabine up to 3 g/m2, is permitted for control of counts prior to treatment. 2. Patients \>/= 60 are eligible if not a candidate for standard cytarabine plus anthracycline chemotherapy as determined by Kantarjian's score (Appendix D) Patients younger than 60 may also be included if felt not to be a candidate for intensive anthracycline plus cytarabine based chemotherapy. 3. Performance 0-3 (ECOG). 4. Adequate liver function (Total bilirubin of \< 2 mg/dl) unless due to hemolysis, leukemia organ infiltration or Gilbert's syndrome and renal function (creatinine \< 2.5 mg/dl). 5. Signed informed consent Exclusion Criteria: 1. Nursing and pregnant females. Female patients of childbearing potential and male patients should practice effective methods of contraception such as double barrier method. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Negative urine pregnancy test (women of childbearing potential) 2. Active and uncontrolled infections. 3. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, active significant other cancers requiring chemotherapy and/or radiation therapy within past 6 months (excluding non-melanoma skin cancer) or psychiatric illness/social situations that would limit compliance with study requirements.
References
Publications (1)
- DERIVEDShort NJ, Kantarjian HM, Loghavi S, Huang X, Qiao W, Borthakur G, Kadia TM, Daver N, Ohanian M, Dinardo CD, Estrov Z, Kanagal-Shamanna R, Maiti A, Benton CB, Bose P, Alvarado Y, Jabbour E, Kornblau SM, Pemmaraju N, Jain N, Gasior Y, Richie MA, Pierce S, Cortes J, Konopleva M, Garcia-Manero G, Ravandi F. Treatment with a 5-day versus a 10-day schedule of decitabine in older patients with newly diagnosed acute myeloid leukaemia: a randomised phase 2 trial. Lancet Haematol. 2019 Jan;6(1):e29-e37. doi: 10.1016/S2352-3026(18)30182-0. Epub 2018 Dec 10. PMID 30545576