Prospective randomized multicenter phase III trial of decitabine and venetoclax administered in combination with all-trans retinoic acid or placebo in patients with acute myeloid leukemia who are ineligible for induction chemotherapy - DECIDER-2 trial

Trial details

Who runs it

Medical Center - University Of Freiburg

Trial code

EU 2023-507461-26-00

Record updated

2026. szeptember 2.

Original description

To compare the efficacy of all-trans retinoic acid (ATRA) versus placebo as addon to the backbone treatment (DAC and VEN) with respect to overall survival (OS)Read full original descriptionShow less

To compare the efficacy of all-trans retinoic acid (ATRA) versus placebo as addon to the backbone treatment (DAC and VEN) with respect to overall survival (OS)

Inclusion: Age ≥ 18 years; Previously untreated AML (WHO 2016); ECOG ≤ 2; White blood cell count < 25×109/L (hydroxyurea or Ara-C are permitted to meet this criterion,; Patients considered not to benefit from the induction therapy or whom standard induction chemotherapy is not feasible; the following criteria are accepted (example): - age ≥ 75 years - - ECOG ≥ 1 - - HCT-CI ≥ 3 - adverse genetics - - patient declines standard aggressive chemotherapy - missing social support system; Projected life expectancy of at least 8 weeks; Written informed consent obtained according to international guidelines and local laws; Ability to understand the nature, significance and consequences of the trial and the trial related procedures and to comply with them.

Exclusion: Any malignancy requiring chemotherapy for which the patient received chemotherapy within 3 months prior to randomization; Participation in any other interventional clinical trial within the last 30 days before randomization; Known or persistent abuse of medication, drugs or alcohol; Previous treatment with DAC, azacitidine, or other DNA-hypomethylating agents, ATRA, venetoclax and other Bcl-2 inhibitors; Previous allogeneic stem cell transplantation or solid organ transplantation; Previous induction chemotherapy; 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 prescribed by the clinical trial protocol; the patient must have recovered from all clinically relevant reversible non-hematologic toxicities; Known allergy against soy-beans or peanuts (due to ATRA excipients); Known hypersensitivity to or intolerance of one of the trial drugs or its constituents (e.g. other retinoids (ATRA) or sunset yellow FCF E110); Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic; 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; Known positivity for HIV, Hepatitis B or Hepatitis C; Uncontrolled bacterial, viral or fungal infection; Known rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption; Severe congestive heart failure, clinically unstable cardiac disease or QTc prolongation ≥ CTCAE grade 3; Acute promyelocytic leukemia (APL, FAB M3); Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed; Patient without legal capacity; Person who is in a relationship of dependence/employment with the sponsor or the investigator; Current or planned pregnancy, nursing period; Central nervous system (CNS) leukemia.

EU CTIS 2023-507461-26-00