Clinical trial · Interventional
Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Phase II Study of Maintenance Therapy With Decitabine (NSC #127716) Following Standard Induction and Cytogenetic Risk-Adapted Intensification in Previously Untreated Patients With AML < 60 Years
NCT00416598CI-TRIAL-00037161completedPhase 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)
This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back.
Conditions
Conditions (7)
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 |
| Acute Myeloid Leukemia With Myelodysplasia-Related Changes | Acute Myeloid Leukemia, Myelodysplasia-Related | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 | Adult Acute Myeloid Leukemia with inv(16)(p13.1q22); CBFB-MYH11 | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11 | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 | Adult Acute Myeloid Leukemia with t(8;21)(q22;q22.1); RUNX1-RUNX1T1 | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Bone Marrow Transplantation | Procedure | — | UNRESOLVED |
| Autologous Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Daunorubicin Hydrochloride | Drug | Daunorubicin | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy, PBSC or bone marrow transplantation)
- description
- See Detailed Description.
- interventionNames
- Procedure: Autologous Bone Marrow Transplantation
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Drug: Busulfan
- Drug: Cytarabine
- Drug: Daunorubicin Hydrochloride
- Drug: Decitabine
- Drug: Etoposide
- Biological: Filgrastim
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
Primary outcomes (2)
- measure
- Number of Participants Who Completed Maintenance Decitabine.
- timeFrame
- Up to 5 years
- description
- To determine feasibility of decitabine maintenance, this outcome measures the number of participants who completed all 8 planned cycles of decitabine maintenance as per protocol.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * Unequivocal histologic diagnosis of AML (\> 20% blasts in the bone marrow based on the World Health Organization \[WHO\] and/or French American British \[FAB\] classifications), excluding M3 (acute promyelocytic leukemia); patients with antecedent myelodysplasia are eligible for treatment on this trial only if there were no bone marrow biopsy showing myelodysplastic syndrome (MDS) \> 3 months prior to enrollment; patients with therapy-related AML are eligible if they have been free of their primary disease and have not received any chemotherapy for at least 2 years * No prior 5-azacitidine or decitabine therapy * No prior treatment for leukemia or myelodysplastic syndrome with four permissible exceptions: * Emergency leukapheresis * Emergency treatment for hyperleukocytosis with hydroxyurea * Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only) * Growth factor/cytokine support
References
Publications (3)
- DERIVEDSeffernick AE, Mrozek K, Nicolet D, Stone RM, Eisfeld AK, Byrd JC, Archer KJ. High-dimensional genomic feature selection with the ordered stereotype logit model. Brief Bioinform. 2022 Nov 19;23(6):bbac414. doi: 10.1093/bib/bbac414. PMID 36184192
- DERIVEDYin J, LaPlant B, Uy GL, Marcucci G, Blum W, Larson RA, Stone RM, Mandrekar SJ. Evaluation of event-free survival as a robust end point in untreated acute myeloid leukemia (Alliance A151614). Blood Adv. 2019 Jun 11;3(11):1714-1721. doi: 10.1182/bloodadvances.2018026112. PMID 31171508
- DERIVEDBlum W, Sanford BL, Klisovic R, DeAngelo DJ, Uy G, Powell BL, Stock W, Baer MR, Kolitz JE, Wang ES, Hoke E, Mrozek K, Kohlschmidt J, Bloomfield CD, Geyer S, Marcucci G, Stone RM, Larson RA; Alliance for Clinical Trials in Oncology. Maintenance therapy with decitabine in younger adults with acute myeloid leukemia in first remission: a phase 2 Cancer and Leukemia Group B Study (CALGB 10503). Leukemia. 2017 Jan;31(1):34-39. doi: 10.1038/leu.2016.252. Epub 2016 Sep 13. PMID 27624549