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Compares treatment options for Acute Myeloid Leukemia
Official title Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML
ClinicalTrials.gov ID: NCT05904106
What this study is testing
What is Venetoclax plus Azacitidine?
Venetoclax plus Azacitidine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II clinical trial evaluates the efficacy and tolerability of the non-intensive treatment with venetoclax and the hypomethylating agent azacitidine as compared to the standard of care chemotherapy plus gemtuzumab ozogamicin in newly diagnosed NPM1 mutated AML patients fit for intensive chemotherapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- A signed informed consent
- Newly diagnosed CD33-positive AML with NPM1 mutation according to WHO criteria
- Age 18-70 years
- Fit for intensive chemotherapy, defined by
- ECOG performance status of 0-2
You likely can't join if
- Activating FLT3 mutation
- Relapsed or refractory AML
- AML after antecedent myelodysplasia (MDS) with prior cytotoxic treatment
- Prior history of malignancy, other than MDS, unless the subject has been free of the disease for ≥ 1 year prior to start of study treatment...
- Previous treatment with HMA or venetoclax
- Previous treatment for AML except hydroxyurea
See the full eligibility criteria
- A signed informed consent
- Newly diagnosed CD33-positive AML with NPM1 mutation according to WHO criteria
- Age 18-70 years
- Fit for intensive chemotherapy, defined by
- ECOG performance status of 0-2
- Adequate hepatic function: ALAT/ASAT/Bilirubin ≤ 2.5 x ULN unless considered due to leukemic organ involvement Note: people with Gilbert's Syndrome may have a bilirubin \> 2.5 × ULN per discussion between the...
- Adequate renal function assessed by serum creatinine ≤ 1.5x ULN OR creatinine clearance (by Cockcroft Gault formula) ≥ 50 mL/min
- WBC \< 25 x 109/L (\<25,000/µL), prior hydroxyurea is permitted to meet this criterion
- Ability to understand and the willingness to sign a written informed consent.
- Male people must agree to refrain from unprotected sex and sperm donation from time point of signing the informed consent until 7 months after the last dose of study drug.
- Women of childbearing potential must have a negative serum or urine pregnancy test performed within 72 hours before first dose of study drug.
- Activating FLT3 mutation
- Relapsed or refractory AML
- AML after antecedent myelodysplasia (MDS) with prior cytotoxic treatment
- Prior history of malignancy, other than MDS, unless the subject has been free of the disease for ≥ 1 year prior to start of study treatment (exceptions are basal or squamous cell carcinoma of the skin, carcinoma in situ...
- Previous treatment with HMA or venetoclax
- Previous treatment for AML except hydroxyurea
- Cumulative previous exposure to anthracyclines of \> 200 mg/m\^2 doxorubicin equivalents
- CNS involvement or extramedullary disease only
- Known hypersensitivity to excipients of the preparation or any agent given in association with this study including venetoclax, azacitidine, cytarabine, daunorubicin, gemtuzumab-ozogamicin, or mitoxantrone
- Known positivity for human immunodeficiency virus (HIV) and History of active or chronic infectious hepatitis unless serology demonstrates clearance of infection (i.e. PCR undetectable viral load for hepatitis).
- Inability to swallow oral medications
- Any malabsorption condition
- Cardiovascular disability status of New York Heart Association (NYHA) Class ≥ 2; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias...
- Chronic respiratory disease that requires continuous oxygen use
- Substance abuse, medical, psychological, or social conditions that may interfere with the subject's cooperation with the requirements of the trial or evaluation of the study results
- Simultaneous participation in another treatment clinical trial
- Pregnant or breastfeeding women. Breastfeeding has to be discontinued before onset of and during treatment and should be discontinued for at least 3 months after end of treatment.
- Patients who are unwilling to follow strictly highly effective contraception requirements including hormonal contraceptives with an Pearl Index \< 1% per year in combination with a barrier method from time point of...
- post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH \> 40 U/ml)
- postoperative (6 weeks after bilateral ovarectomy with or without hysterectomy)
- medically confirmed ovarian failure
- vasectomy Note: At present, it is not known whether the how well it works of hormonal contraceptives is reduced by venetoclax. For this reason, women must use a barrier method in addition to hormonal contraceptive...
- History of clinically significant liver cirrhosis (e.g., Child-Pugh class B and C)
- Live-virus vaccines given within 28 days prior to the initiation of study treatment Note: corona vaccines are not live-virus vaccines and are excluded from this criterion.
The study team makes the final eligibility decision.
Where it's taking place
- Essen, North Rhine-Westphalia, Germany
- Aachen, Germany
- Augsburg, Germany
- Chemnitz, Germany
- Cologne, Germany
- Dresden, Germany
- Erlangen, Germany
- Frankfurt am Main, Germany
- Halle, Germany
- Heidelberg, Germany
- Kiel, Germany
- Leipzig, Germany
- Mannheim, Germany
- Marburg, Germany
- Münster, Germany
- Nuremberg, Germany
- Regensburg, Germany
- Stuttgart, Germany
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, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Essen, North Rhine-Westphalia, Germany; Aachen, Germany; Augsburg, Germany; Chemnitz, Germany; Cologne, Germany; Dresden, Germany and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.