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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
EU CTIS ID: 2023-507461-26-00
What this study is testing
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)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Acute promyelocytic leukemia (APL, FAB M3)
- 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)
- Known rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- Acute promyelocytic leukemia (APL, FAB M3)
- 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)
- Known rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
- 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
- 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
- Known or persistent abuse of medication, drugs or alcohol
- Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic
- Person who is in a relationship of dependence/employment with the sponsor or the investigator
- Previous treatment with DAC, azacitidine, or other DNA-hypomethylating agents, ATRA, venetoclax and other Bcl-2 inhibitors
- Current or planned pregnancy, nursing period
- 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.
- 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
- Central nervous system (CNS) leukemia
- Severe congestive heart failure, clinically unstable cardiac disease or QTc prolongation ≥ CTCAE grade 3
- Known positivity for HIV, Hepatitis B or Hepatitis C
- Uncontrolled bacterial, viral or fungal infection
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.