C92
Conditions
Interventions
Group 1: Backbone treatment:
• DAC intravenously (i.v.) 20 mg/m2 over 1h, on day 1 to day 5 (total dose 100 mg/m2) and
• VEN per os (p.o.) ramp-up (during posaconazole prophylaxis, which is strongly r
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Previously untreated AML (WHO 2016) 3. ECOG = 2 4. White blood cell count < 25 × 109/L (hydroxyurea or Ara-C are permitted to meet this criterion see section 6.6.2) 5. Patients for whom standard intensive induction chemotherapy is not feasible, patients not considered to benefit from standard intensive induction chemotherapy; the following criteria are generally accepted (examples): • age = 75 years • ECOG = 1 • HCT-CI = 3 • adverse genetics • patient declines standard aggressive chemotherapy • missing social support system 6. Projected life expectancy of at least 8 weeks 7. Written informed consent obtained according to international guidelines and local laws 8. Ability to understand the nature, significance and consequences of the trial and the trial related procedures and to comply with them
Exclusion criteria
Exclusion criteria: 1. Acute promyelocytic leukemia (APL, FAB M3) 2. Previous treatment with DAC, azacitidine, or other DNA-hypomethylating agents, ATRA, venetoclax and other Bcl-2 inhibitors 3. Previous allogeneic stem cell transplantation or solid organ transplantation 4. Previous induction chemotherapy 5. Previous low-dose chemotherapy (e.g. hydroxyurea, cytosine arabinoside (Ara-C), melphalan etc.) within 4 weeks prior to the first administration of study treatment, except for cytoreduction of leukocytosis = 25,000/µl with hydroxyurea or Ara-C as proscribed by the clinical trial protocol (section 6.6.2); the patient must have recovered from all clinically relevant reversible non-hematologic toxicities 6. Central nervous system (CNS) leukemia 7. Severe congestive heart failure or clinically unstable cardiac disease or QTc prolongation = CTCAE grade 3 8. Known positivity for HIV, Hepatitis B# or Hepatitis C 9. Uncontrolled bacterial, viral or fungal infection 10. Known allergy against soy-beans or peanuts (due to ATRA excipients) 11. Known hypersensitivity to or intolerance of one of the trial drugs or its constituents (e.g. other retinoids or sunset yellow FCF E110) 12. Known rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption 13. Any malignancy requiring chemotherapy for which the patient received chemotherapy within 3 months prior to randomization 14. Participation in any other interventional clinical trial within the last 30 days before randomization 15. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed 16. Patient without legal capacity 17. Known or persistent abuse of medication, drugs or alcohol 18. Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic 19. Person who is in a relationship of dependence/employment with the sponsor or the investigator 20. Current or planned pregnancy, nursing period 21. For fertile patients: failure to use one of the following safe methods of contraception: intra-uterine device or hormonal contraception in combination with a mechanical method of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) time | — |
Secondary
| Measure | Time frame |
|---|---|
| • Objective best response (CR, CRi, MLFS or PR) • CR with negative MRD (CRMRD-) • OS time with objective best response (CR, CRi, MLFS or PR) • Quality of life (EORTC QLQ-C30) (especially fatigue) and FACIT Fatigue Scale | — |
Countries
Germany
Contacts
Public ContactMichael Lübber
Department of Medicine I: Hematology, Oncology, and Stem-Cell Transplantation
Outcome results
None listed