Clinical trial · Interventional
All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Phase III - Study on All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT00151255CI-TRIAL-00027075completedPhase 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 study looking at all-trans retinoic acid in combination with standard induction and consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML).
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| All-trans retinoic acid | Drug | Tretinoin | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposid | Drug | — | UNRESOLVED |
| Idarubicin | Drug | Idarubicin | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- event-free survival
- timeFrame
- two years
Secondary outcomes (5)
- measure
- kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs
- timeFrame
- during therapy
- measure
- complete remission (CR) rate after induction therapy
- timeFrame
- after second induction cycle
- measure
- cumulative incidence of relapse
- timeFrame
- two years
- measure
- cumulative incidence of death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 61 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed AML defined according to the World Health Organization (WHO) classification (excluding acute promyelocytic leukemia \[APL\]) * Aged \> 60 years * All patients have to be informed about the character of the study. Written informed consent of each patient at study entry. * Molecular and cytogenetical analyses on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories. Exclusion Criteria: * Bleeding independent of the AML * Acute promyelocytic leukemia * Uncontrolled infection * Participation in a concurrent clinical study * Insufficiency of the kidneys (creatinine \> 1.5 x upper normal serum level), of the liver (bilirubin, AST or AP \> 2 x upper normal serum level), severe obstruction or restrictive ventilation disorder, heart failure New York Heart Association \[NYHA\] III/IV * Severe neurological or psychiatric disorder interfering with ability of giving informed consent * No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course * Performance status WHO \> 2
References
Publications (2)
- DERIVEDTassara M, Dohner K, Brossart P, Held G, Gotze K, Horst HA, Ringhoffer M, Kohne CH, Kremers S, Raghavachar A, Wulf G, Kirchen H, Nachbaur D, Derigs HG, Wattad M, Koller E, Brugger W, Matzdorff A, Greil R, Heil G, Paschka P, Gaidzik VI, Gottlicher M, Dohner H, Schlenk RF. Valproic acid in combination with all-trans retinoic acid and intensive therapy for acute myeloid leukemia in older patients. Blood. 2014 Jun 26;123(26):4027-36. doi: 10.1182/blood-2013-12-546283. Epub 2014 May 5. PMID 24797300
- DERIVEDSchlenk RF, Taskesen E, van Norden Y, Krauter J, Ganser A, Bullinger L, Gaidzik VI, Paschka P, Corbacioglu A, Gohring G, Kundgen A, Held G, Gotze K, Vellenga E, Kuball J, Schanz U, Passweg J, Pabst T, Maertens J, Ossenkoppele GJ, Delwel R, Dohner H, Cornelissen JJ, Dohner K, Lowenberg B. The value of allogeneic and autologous hematopoietic stem cell transplantation in prognostically favorable acute myeloid leukemia with double mutant CEBPA. Blood. 2013 Aug 29;122(9):1576-82. doi: 10.1182/blood-2013-05-503847. Epub 2013 Jul 17. PMID 23863898