Acute Myeloid LeukemiaPhase 2VINCENTNCT05904106
Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML
A Phase 2 study testing Venetoclax plus Azacitidine in people with Acute Myeloid Leukemia, run by Technische Universität Dresden at 18 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Venetoclax plus Azacitidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 18 sitesGermany
- Study dates
- 7 Apr 2024to Sep 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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: Subjects with Gilbert's Syndrome may have a bilirubin > 2.5 × ULN per discussion between the investigator and Coordinating investigator.
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- 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 subjects 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.
Who cannot join
- 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 of the cervix or of the breast, incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis clinical staging system))
- Previous treatment with HMA or venetoclax
- Previous treatment for AML except hydroxyurea
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- 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 requiring anti-arrhythmic therapy.
- Note: Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.
- 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 interventional 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 signing the informed consent until 7 months after the last dose of study drug unless one of the following criteria is met:
- 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 effectiveness of hormonal contraceptives is reduced by venetoclax. For this reason, women must use a barrier method in addition to hormonal contraceptive methods.
- 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.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
Germany18 sites, 18 recruiting
- Recruiting
Universitätsklinikum Aachen
Aachen, 52074
Edgar Jost, Prof.
- Recruiting
Universitätsklinikum Augsburg
Augsburg, 86156
Christoph Schmid, Prof.
- Recruiting
Klinikum Chemnitz gGmbH
Chemnitz, 09116
Mathias Hänel, Prof.
- Not yet recruiting
Universiätsklinikum Köln
Cologne, 50937
- Recruiting
Universitätsklinikum Dresden
Dresden, 01307
Christoph Röllig, Prof.
- Recruiting
Universitätsklinikum Erlangen
Erlangen, 91054
Stefan Krause, Prof.
- Recruiting
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Maher Hanoun, PD Dr.
- Recruiting
Johann Wolfgang Goethe-Universität
Frankfurt am Main, 60590
Björn Steffen, Dr.
- Recruiting
Universitätsklinikum Halle
Halle, 06120
Christine Dierks, Prof.
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
Tim Sauer, Dr.
- Recruiting
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
Lars Fransecky, Dr.
- Recruiting
Universitätsklinikum Leipzig
Leipzig, 04103
Klaus Metzeler, Prof.
- Recruiting
Klinikum Mannheim gGmbH
Mannheim, 68167
Nadine Müller, Dr.
- Recruiting
Philipps-Universität Marburg Fachbereich Medizin
Marburg, 35043
Andreas Neubauer, Prof.
- Recruiting
Universitätsklinikum Münster
Münster, 48149
Christoph Schliemann, Prof.
- Recruiting
Klinikum Nürnberg-Nord
Nuremberg, 90419
Kerstin Schäfer-Eckart, Dr.
- Recruiting
Krankenhaus Barmherzige Brüder
Regensburg, 93049
Nadia Maguire
- Recruiting
Robert-Bosch-Krankenhaus
Stuttgart, 70376
Martin Kaufmann, Dr.
About this study
Official title: Venetoclax Plus Azacitidine Versus Standard Intensive Chemotherapy for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and NPM1 Mutations Eligible for Intensive Treatment
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.
Read the detailed description
AML is a heterogeneous disease of malignant early myeloid cells with a poor prognosis. Currently the only potentially curative treatment for patients with AML is intensive induction chemotherapy with 7 days of standard-dose cytarabine plus 3 days of an anthracyclin (7+3) followed either by several courses of consolidation chemotherapy with high-dose cytarabine or by allogeneic stem cell transplantation as standard of care (SOC). Complete remission (CR) is achieved in 60-80% of younger patients (aged 16-60 years) and in around 50% of older patients aged ≥ 60 years by this induction chemotherapy. However, this induction chemotherapy is toxic, due to prolonged myelosuppression with resulting infectious complications and organ toxicity with severe nausea, mucositis, colitis and cardiotoxicity. Each cycle of this intensive chemotherapy usually results in prolonged hospitalization of the patients and requires extensive supportive care with blood products and anti-infective agents. In addition, patients treated with intensive induction chemotherapy are at increased risk for several serious long-term side effects including cardiac and neurological sequelae, infertility and secondary cancers. The high toxicity burden in general and cardiovascular toxicity specifically consistently increase total costs in intensive induction and consolidation chemotherapy. From this perspective there is a need for therapies with lower toxicity and better efficacy.
Due to the high risk of early mortality, older patients and those with severe pre-existing conditions are typically treated with non-intensive chemotherapy with either low-dose cytarabine (LDAC) or a hypomethylating agent (HMA) either azacitidine or decitabine.While these treatments offer at best modest efficacy with CR rates of only 10%-30% and median overall survival of 6-12 months, combinations with the B-cell lymphoma-2 inhibitor venetoclax have been shown to produce CR rates between 50-75% in patients not eligible for intensive chemotherapy. The best response of venetoclax-based regimens with response rates up to 93% and two-year overall survival of 75% has been found among others in the large group of AML patients with mutations in the NPM1 gene. Standard intensive treatment in NPM1 mutated AML patients without adverse risk features usually consisting of standard of care chemotherapy plus gemtuzumab ozogamicin (GO) induces CR rates around 85%, and leads to a 5-year overall survival of around 40% - 50%.The rate and durability of response to venetoclax-based combinations in single arm studies with NPM1 mutated AML patients compared favourably with outcomes from intensive chemotherapy. A retrospective analysis in elderly AML patients with NPM1 mutation found remission rates of 73% in the entire cohort and 96 % in patients > 65 years. The venetoclax-based combination with the HMA azacitidine is generally well tolerated and has a better safety profile than intensive chemotherapy.
Based on these available clinical data it is postulated that non-intensive treatment with venetoclax plus azacitidine in NPM1 mutated fit AML patients may be equivalent or superior to the standard intensive treatment in terms of remission rates, relapse-free survival, treatment related mortality and health-related quality of life. This randomised controlled phase II trial (VINCENT) is to evaluate the efficacy and tolerability of the non-intensive treatment with venetolcax and azacitidine (Ven+Aza arm) in a wide age-range of newly diagnosed NPM1 mutated AML patients fit for intensive chemotherapy in comparison to standard of care chemotherapy plus GO (SOC arm).
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Venetoclax plus Azacitidine, standard of care chemotherapy plus gemtuzumab ozogamicin
- Keywords
- AML, NPM1, venetoclax, azacitidine, Measurable Residual Disease
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venetoclax plus AzacitidineDrug
Induction cycle 1:
100 mg venetoclax p.o. on day 1; 200 mg venetoclax p.o. on day 2; 400 mg venetoclax p.o. on days 3-28; 75 mg/m^2 azacitidine s.c. on days 1-7
Induction cycles 2-3:
400 mg venetoclax p.o. on days 1-28; 75 mg/m^2 azacitidine s.c. on days 1-7
Postremission cycles 1-9:
400 mg venetoclax p.o. on days 1-28; 75 mg/m^2 azacitidine s.c. on days 1-7
standard of care chemotherapy plus gemtuzumab ozogamicinDrug
Induction cycle 1:
200 mg/m^2 cytarabine cont inf i.v. on days 1-7; 60 mg/m^2 daunorubicin i.v. on days 3-5; 3 mg/m^2 (max 1 vial) gemtuzumab ozogamicin i.v. on days 1+4+7
Induction cycle 2 (patients not in remission, moderate or non-responders):
3000/1000 mg/m^2 cytarabine i.v. BID on days 1-3; 10 mg/m^2 mitoxantrone i.v. on days 3-5
Postremission cycles 1-3:
3000/1000 mg/m^2 cytarabine i.v. BID on days 1-3
| Study group | Role | What they receive |
|---|---|---|
| Ven+Aza arm | Experimental | non-intensive treatment: venetoclax plus azacitidine Receives: Drug: Venetoclax plus Azacitidine |
| SOC arm | Active comparator | standard of care treatment: intensive chemotherapy plus gemtuzumab ozogamicin Receives: Drug: standard of care chemotherapy plus gemtuzumab ozogamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified event-free survival (mEFS)
- Failure to achieve a CR/CRi/CRh after a maximum of two induction cycles in the control arm (SOC) or three induction cycles in the investigational arm (VEN+AZA), i.e. primary induction failure
- Hematologic relapse after previous CR/CRi/CRh
- Molecular failure, defined as either
- Molecular progression, defined as confirmed ≥ 1 log10 increase of NPM1 MRD level in any two samples in a patient without prior MRD negativity or
- Molecular relapse after previous MRD negativity, defined as confirmed ≥ 1 log10 between two consecutive positive samples in a patient who was previously tested as MRD negative
- Death
Measured: time interval from date of randomization until either primary treatment failure or hematologic relapse or molecular failure or death, whichever occurs first
Secondary outcomes (8)
Tolerability of treatment
cumulative occurence of CTCAE grade 3 and grade 4 adverse events
Measured: from FPFV until LPLV [4 years]
Remission (CR/CRi/CRh) rate
CR/CRi/CRh rate is defined as the proportion of patients, who achieved a CR or CRi or CRh during study participation.
Measured: from FPFV until LPLV [4 years]
molecular response rate
Proportion of patients with absence of detectable NPM1 mutant transcripts or with detectable NPM1 mutant transcripts who do not meet any of the definitions of molceular failure during study participation.
Measured: from FPFV until LPLV [4 years]
molecular persistence rate
Proportion of patients with detectable NPM1 mutant transcripts present after four cycles of treatment with less than a 4 log10 reduction from baseline.
Measured: from FPFV until LPLV [4 years]
Rate of CR/CRi/CRh with MRD negativity
Proportion of patients, who achieved a CR or CRi or CRh with NPM1-mutant transcripts/ABL1 transcripts <0.01% during study participation.
Measured: from FPFV until LPLV [4 years]
early mortality
Early mortality is defined as death from any reason within 14, 30 and 60 days from day 1 of induction treatment.
Measured: from FPFV until LPLV [4 years]
Relapse-free survival (RFS)
Relapse-free survival is defined as the time interval from date of first CR/CRi/CRh until either morphologic or molecular relapse or death in remission.
Measured: from FPFV until LPLV [4 years]
Overall survival (OS)
Overall survival is defined as time interval from date of randomization until death from any cause.
Measured: from FPFV until LPLV [4 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start7 Apr 2024
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie, University Hospital Heidelberg
- Responsible party
- Sponsor
- Investigators
- Christoph Röllig, Prof., Principal investigator, Technische Universität Dresden, Medical Faculty Carl Gustav Carus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904106
- Sponsor's protocol ID
- TUD-VINC01-080
- Acronym
- VINCENT
- Status last verified
- Aug 2026
- First submitted
- 25 May 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax Plus Azacitidine Versus Standard Intensive Chemotherapy for Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and NPM1 Mutations Eligible for Intensive Treatment
- ClinicalTrials.gov ID
- NCT05904106
- Acronym / sponsor ID
- VINCENT / TUD-VINC01-080
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, NPM1, venetoclax, azacitidine, Measurable Residual Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- AbbVie, University Hospital Heidelberg
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
AML is a heterogeneous disease of malignant early myeloid cells with a poor prognosis. Currently the only potentially curative treatment for patients with AML is intensive induction chemotherapy with 7 days of standard-dose cytarabine plus 3 days of an anthracyclin (7+3) followed either by several courses of consolidation chemotherapy with high-dose cytarabine or by allogeneic stem cell transplantation as standard of care (SOC). Complete remission (CR) is achieved in 60-80% of younger patients (aged 16-60 years) and in around 50% of older patients aged ≥ 60 years by this induction chemotherapy. However, this induction chemotherapy is toxic, due to prolonged myelosuppression with resulting infectious complications and organ toxicity with severe nausea, mucositis, colitis and cardiotoxicity. Each cycle of this intensive chemotherapy usually results in prolonged hospitalization of the patients and requires extensive supportive care with blood products and anti-infective agents. In addition, patients treated with intensive induction chemotherapy are at increased risk for several serious long-term side effects including cardiac and neurological sequelae, infertility and secondary cancers. The high toxicity burden in general and cardiovascular toxicity specifically consistently increase total costs in intensive induction and consolidation chemotherapy. From this perspective there is a need for therapies with lower toxicity and better efficacy.
Due to the high risk of early mortality, older patients and those with severe pre-existing conditions are typically treated with non-intensive chemotherapy with either low-dose cytarabine (LDAC) or a hypomethylating agent (HMA) either azacitidine or decitabine.While these treatments offer at best modest efficacy with CR rates of only 10%-30% and median overall survival of 6-12 months, combinations with the B-cell lymphoma-2 inhibitor venetoclax have been shown to produce CR rates between 50-75% in patients not eligible for intensive chemotherapy. The best response of venetoclax-based regimens with response rates up to 93% and two-year overall survival of 75% has been found among others in the large group of AML patients with mutations in the NPM1 gene. Standard intensive treatment in NPM1 mutated AML patients without adverse risk features usually consisting of standard of care chemotherapy plus gemtuzumab ozogamicin (GO) induces CR rates around 85%, and leads to a 5-year overall survival of around 40% - 50%.The rate and durability of response to venetoclax-based combinations in single arm studies with NPM1 mutated AML patients compared favourably with outcomes from intensive chemotherapy. A retrospective analysis in elderly AML patients with NPM1 mutation found remission rates of 73% in the entire cohort and 96 % in patients > 65 years. The venetoclax-based combination with the HMA azacitidine is generally well tolerated and has a better safety profile than intensive chemotherapy.
Based on these available clinical data it is postulated that non-intensive treatment with venetoclax plus azacitidine in NPM1 mutated fit AML patients may be equivalent or superior to the standard intensive treatment in terms of remission rates, relapse-free survival, treatment related mortality and health-related quality of life. This randomised controlled phase II trial (VINCENT) is to evaluate the efficacy and tolerability of the non-intensive treatment with venetolcax and azacitidine (Ven+Aza arm) in a wide age-range of newly diagnosed NPM1 mutated AML patients fit for intensive chemotherapy in comparison to standard of care chemotherapy plus GO (SOC arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ven+Aza arm | Experimental | Drug: Venetoclax plus Azacitidinenon-intensive treatment: venetoclax plus azacitidine |
| SOC arm | Active comparator | Drug: standard of care chemotherapy plus gemtuzumab ozogamicinstandard of care treatment: intensive chemotherapy plus gemtuzumab ozogamicin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- WBC < 25 x 109/L (<25,000/µL), prior hydroxyurea is permitted to meet this criterion
Key exclusion criteria (26 listed)
- 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 of the cervix or of the breast, incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis clinical staging system))
- Previous treatment with HMA or venetoclax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venetoclax plus AzacitidineInduction cycle 1: 100 mg venetoclax p.o. on day 1; 200 mg venetoclax p.o. on day 2; 400 mg venetoclax p.o. on days 3-28; 75 mg/m^2 azacitidine s.c. on days 1-7 Induction cycles 2-3: 400 mg venetoclax p.o. on days 1-28; 75 mg/m^2 azacitidine s.c. on days 1-7 Postremission cycles 1-9: 400 mg venetoclax p.o. on days 1-28; 75 mg/m^2 azacitidine s.c. on days 1-7 | Drug | Ven+Aza arm |
| standard of care chemotherapy plus gemtuzumab ozogamicinInduction cycle 1: 200 mg/m^2 cytarabine cont inf i.v. on days 1-7; 60 mg/m^2 daunorubicin i.v. on days 3-5; 3 mg/m^2 (max 1 vial) gemtuzumab ozogamicin i.v. on days 1+4+7 Induction cycle 2 (patients not in remission, moderate or non-responders): 3000/1000 mg/m^2 cytarabine i.v. BID on days 1-3; 10 mg/m^2 mitoxantrone i.v. on days 3-5 Postremission cycles 1-3: 3000/1000 mg/m^2 cytarabine i.v. BID on days 1-3 | Drug | SOC arm |
Primary outcome
modified event-free survival (mEFS)
Time frame: time interval from date of randomization until either primary treatment failure or hematologic relapse or molecular failure or death, whichever occurs first
* Failure to achieve a CR/CRi/CRh after a maximum of two induction cycles in the control arm (SOC) or three induction cycles in the investigational arm (VEN+AZA), i.e. primary induction failure * Hematologic relapse after previous CR/CRi/CRh * Molecular failure, defined as either * Molecular progression, defined as confirmed ≥ 1 log10 increase of NPM1 MRD level in any two samples in a patient without prior MRD negativity or * Molecular relapse after previous MRD negativity, defined as confirmed ≥ 1 log10 between two consecutive positive samples in a patient who was previously tested as MRD negative * Death
8 secondary outcomes
Tolerability of treatment
Time frame: from FPFV until LPLV [4 years]
Remission (CR/CRi/CRh) rate
Time frame: from FPFV until LPLV [4 years]
molecular response rate
Time frame: from FPFV until LPLV [4 years]
molecular persistence rate
Time frame: from FPFV until LPLV [4 years]
Rate of CR/CRi/CRh with MRD negativity
Time frame: from FPFV until LPLV [4 years]
early mortality
Time frame: from FPFV until LPLV [4 years]
Relapse-free survival (RFS)
Time frame: from FPFV until LPLV [4 years]
Overall survival (OS)
Time frame: from FPFV until LPLV [4 years]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph Röllig, Prof. principal investigator
Technische Universität Dresden, Medical Faculty Carl Gustav Carus
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax plus Azacitidine in people with Acute Myeloid Leukemia, run by Technische Universität Dresden at 18 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manja Reimann, Dr. (+49 351 458 ext. 3091, vincent@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified event-free survival (mEFS) (time frame: time interval from date of randomization until either primary treatment failure or hematologic relapse or molecular failure or death, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.