A Phase 3 interventional study of Venetoclax and Placebo in Acute Myeloid Leukemia, sponsored by University of Ulm. Recruiting at 91 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Ulm · Phase 3, Interventional, and Treatment
A Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2
Prospective, multicenter, double-blind, randomized, placebo-controlled phase 3 clinical study. The randomized phase of the study will be preceded by a feasibility run-in dose-escalation phase in patients with AML in which the venetoclax dose for the phase 3 part will be established.
After the feasibility run-in phase, eligible patients will be randomized to intensive chemotherapy with venetoclax or placebo. Patients will receive two cycles of induction chemotherapy; patients achieving CR or CRi after two cycles will continue with consolidation treatment according to initial randomization, and according to Cooperative Group-specific consolidation regimens or investigator choice. Patients achieving morphologic leukemia-free state (MLFS) only, may also continue consolidation treatment on protocol. Assignment to either allogeneic hematopoietic cell transplantation (HCT), conventional chemotherapy or autologous HCT will be done according to institutional standards, and based on (prognostic) disease characteristics, individual patient assessment, and established comorbidity risk scores (e.g., HCT-CI score).
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's planned enrollment of 650 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →University of Ulm is the lead sponsor of 143 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Adequate hepatic function as evidenced by:
Female patient must either:
Be of nonchildbearing potential:
Or, if of (not surgically sterile and not postmenopausal)
And, if heterosexually active, agree to consistently apply one highly effective* method of in combination to a barrier method for the duration of the study and for 27 weeks after the final study drug administration
*Highly effective forms of birth control include
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.
*List is not all inclusive. Prior to enrolment, the investigator is responsible for confirming patient will utilize highly effective forms of birth control in combination with a barrier method according to locally accepted standards during the protocol defined period.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
standard chemotherapy in combination with venetoclax
Drug: Venetoclax · Combination Product: Standard chemotherapy · Other: Allogeneic stem cell transplantation
standard chemotherapy in combination with placebo
Drug: Placebo · Combination Product: Standard chemotherapy · Other: Allogeneic stem cell transplantation
Venetoclax will be administered in Induction cycle 1, Induction cycle 2 and in the chemo consolidation therapy in addition to the standard chemotherapy
Placebo will be administered in Induction cycle 1, Induction cycle 2 and in the chemo consolidation therapy in addition to the standard chemotherapy
Induction cycle 1: Patients will receive cytarabine 200 mg/m2 continuous IV (days 1-7) and daunorubicin 60 mg/m2 IV (days 1-3). Induction cycle 2: Patients ≤ 60 yrs will receive cytarabine 1000 mg/m2 BID (3h IV), days 1-4, and daunorubicin 60 mg/m2 IV (days 1-3). Patients \>60 yrs will receive cytarabine 1000 mg/m2 BID (3h IV), days 1-4 without daunorubicin. Consolidation chemotherapy with intermediate doses of cytarabine. Patients ≤60 yrs will receive up to 3 cycles of IDAC (single dose 1500 mg/m2 every 12 hours, days 1-3). Patients who are \>60 yrs will receive up to 3 cycles of IDAC with single doses of 1000 mg/m2, every 12 hours, days 1-3. In patients \>60 yrs less than 3 cycles of IDAC or dose-reduced IDAC (500 mg/m2 per single dose) may be given based on an individual risk assessment.
Generally, patients will proceed to allogeneic HCT upon completion of remission induction chemotherapy. It is however allowed, as per investigator's discretion, for a patient to receive 'bridging' consolidation chemotherapy in exceptional cases of delay towards transplantation. At baseline, HLA-compatible donor search must be initiated as soon as possible, first among siblings and second in the world donor bank for unrelated donors or cord blood. In order to avoid inappropriate delay in cases where no suitable sibling is present, high-resolution HLA typing should be performed immediately after registration, enabling a more rapid matched-unrelated donor search. In case no sibling or unrelated donor can be identified, haploidentical allogeneic HCT is allowed. Conditioning and GVHD prophylaxis will take place according to institutional guidelines. Patients who undergo allogeneic HCT will not receive venetoclax during conditioning, engraftment or after hematologic recovery.
Event Free Survival (EFS)
EFS in adult patients with newly diagnosed AML, defined as the time from randomization to treatment failure, death from any cause, or relapse after achieving CR or CRi, or start of new therapy due to confirmed molecular relapse whichever occurs first. Treatment failure is defined as not attaining CR or CRi after induction chemotherapy, and EFS event time for treatment failure is Day 1 of post-randomization
Time frame: 6 months/16 months after inclusion of last patient
Frequency of dose-limiting toxicities (DLTs) during the observation period (Primary safety endpoint during dose-finding phase)
Frequency of dose-limiting toxicities (DLTs) during the observation period (from start of cycle 1 up to a maximum of day 42, or until the start of cycle 2)
Time frame: after cycle 1 (maximal day 42)
Overall Survival (OS)
OS in patients with newly diagnosed AML
Time frame: 6 months/16 months/28 months after inclusion of last patient
CR/CRi rate
Complete remission (CR/CRi) rate in newly diagnosed AML patients defined as the proportion of AML patients with CR/CRi after induction chemotherapy
Time frame: 2 months
CR rate
Complete remission (CR) rates in newly diagnosed AML patients defined as the proportion of AML patients with CR after induction chemotherapy
Time frame: 2 months
Event Free Survival (EFS) including CRh
EFS in adult patients with newly diagnosed AML, defined as the time from randomization to treatment failure, death from any cause, or relapse after achieving CR, CRh or CRi, or start of new therapy due to confirmed molecular relapse whichever occurs first. Treatment failure is defined as not attaining CR, CRh or CRi by end of induction chemotherapy, i.e. if a patient's best response during or at completion of the induction treatment is less than CR/CRh/CRi
Time frame: 6 months/16 months after inclusion of last patient
Rates of complete remission without measurable residual disease (CRMRD-) after induction therapy
Rates of complete remission without measurable residual disease (CRMRD-) after induction therapy, defined as the proportion of AML patients achieving CR with negativity for a genetic marker by RT-qPCR, and/or with negativity by multi-color flow cytometry, if studied pre-treatment
Time frame: 2 months
Relapse-free survival (RFS) in newly diagnosed AML patients
Relapse-free survival (RFS) in newly diagnosed AML patients, defined as the time from achievement of a remission (CR/CRh/CRi) following curative therapy (induction and consolidation), to relapse, or start of new therapy due to confirmed molecular relapse or death from any cause
Time frame: 16 months after inclusion of last patient
Cumulative incidence of relapse (CIR) in newly diagnosed AML patients
Cumulative incidence of relapse (CIR) in newly diagnosed AML patients
Time frame: 16 months after inclusion of last patient
Cumulative incidence of death (CID)
Cumulative incidence of death (CID) in newly diagnosed AML patients.
Time frame: 16 months after inclusion of last patient
EQ-5D-5L questionnaire of the EuroQoL (EQ) group, among AML patients
Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated using a 5 level (5L) scale from 1 (minimum) to 5 (maximum). Higher score values mean a worse outcome.
Time frame: at study entry, 2 months, 3 months, 6 months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) among AML patients
All sub scales and single items have values from 1 (minimum) to 100 (maximum) points. A higher point value represents a better condition in terms of the functional scales and quality of life. In the symptomal sub scales a higher point value represents a worse condition.
Time frame: at study entry, 2 months, 3 months, 6 months
Patient Reported Outcome Measurement Information System (PROMIS) Cancer Fatigue short form among AML patients
The 7-item PROMIS Cancer Fatigue Short Form assesses the frequency of fatigue in the past seven days (7). Table 2 presents a list of the items. Items are measured on a five point scale (1 = never; 5 = always) and summed, after reverse scoring item 7, with higher scores indicating greater fatigue (worse condition).
Time frame: at study entry, 2 months, 3 months, 6 months
CR/CRh rate
Complete remission (CR/CRh) rate in newly diagnosed AML patients defined as the proportion of AML patients with CR/CRh after induction chemotherapy
Time frame: 2 months
Rates of complete remission without measurable residual disease (CR/CRh MRD-) after induction therapy
Rates of complete remission without measurable residual disease (CR/CRh MRD-) after induction therapy, defined as the proportion of AML patients achieving CR/CRh with negativity for a genetic marker by RT-qPCR, and/or with negativity by multi-color flow cytometry, if studied pre-treatment
Time frame: 2 months
Rates of complete remission without measurable residual disease (CR/CRi MRD-) after induction therapy
Rates of complete remission without measurable residual disease (CR/CRi MRD-) after induction therapy, defined as the proportion of AML patients achieving CR/CRi with negativity for a genetic marker by RT-qPCR, and/or with negativity by multi-color flow cytometry, if studied pre-treatment
Time frame: 2 months
Rates of CR+CRi in newly diagnosed AML patients after induction 1
Rates of CR+CRi in newly diagnosed AML patients defined as proportion of AML patients achieving CR/CRi after first course of induction
Time frame: 1 month
Rates of CR in newly diagnosed AML patients after induction 1
Rates of CR in newly diagnosed AML patients defined as proportion of AML patients achieving CR after first course of induction
Time frame: 1 month
EFS in newly diagnosed AML patients across different patient subgroups
EFS in newly diagnosed AML patients across different groups are defined based on prognostic characteristics including age at randomization , risk category according to ELN 2022 recommendations, as well as specific AML genotypes
Time frame: 6 months/16 months after inclusion of last patient
OS in newly diagnosed AML patients across different patient subgroups
OS in newly diagnosed AML patients across different groups are defined based on prognostic characteristics including age at randomization , risk category according to ELN 2022 recommendations, as well as specific AML genotypes
Time frame: 6 months/16 months/28 months after inclusion of last patient
CR/CRi rates in newly diagnosed AML patients across different patient subgroups
CR/CRi rates in newly diagnosed AML patients across different groups are defined based on prognostic characteristics including age at randomization , risk category according to ELN 2022 recommendations, as well as specific AML genotypes
Time frame: 2 months
CR rates in newly diagnosed AML patients across different patient subgroups
CR rates in newly diagnosed AML patients across different groups are defined based on prognostic characteristics including age at randomization , risk category according to ELN 2022 recommendations, as well as specific AML genotypes
Time frame: 2 months
RFS in newly diagnosed AML patients across different patient subgroups
RFS in newly diagnosed AML patients across different groups are defined based on prognostic characteristics including age at randomization , risk category according to ELN 2022 recommendations, as well as specific AML genotypes
Time frame: 16 months after inclusion of last patient
CIR in newly diagnosed AML patients across different patient subgroups
CIR in newly diagnosed AML patients across different groups are defined based on prognostic characteristics including age at randomization , risk category according to ELN 2022 recommendations, as well as specific AML genotypes
Time frame: 16 months after inclusion of last patient
CID in newly diagnosed AML patients across different patient subgroups
CID in newly diagnosed AML patients across different groups are defined based on prognostic characteristics including age at randomization , risk category according to ELN 2022 recommendations, as well as specific AML genotypes
Time frame: 16 months after inclusion of last patient
Frequency and severity of AE
Frequency and severity of AE according to CTCAE version 5.0 in newly diagnosed AML patients
Time frame: 6 months
Times to hematopoietic recovery
Times to hematopoietic recovery (absolute neutrophil counts ≥0.5 and ≥1.0 x 109/L; platelets ≥50 and ≥100 x 109/L) after each chemotherapy treatment cycle, defined as the time from the start of the cycle until recovery among AML patients
Time frame: 6 months
EFS with modified definition
To evaluate the impact of venetoclax on EFS in newly diagnosed AML patients using modified endpoint definitions: o Modified EFS includes treatment failure defined as not achieving CR by end of induction chemotherapy assessed by investigator. The date of treatment failure is date of randomization. Patients achieving CRh or CRi are counted as events.
Time frame: 6 months/16 months after inclusion of last patient
RFS with modified definition
To evaluate the impact of venetoclax on RFS in newly diagnosed AML patients using modified endpoint definitions: o Modified RFS includes only subjects achieving CR
Time frame: 16 months after inclusion of last patient
Rates of CR/CRh in newly diagnosed AML patients after induction 1
Rates of CR/CRh in newly diagnosed AML patients defined as proportion of AML patients achieving CR/CRh after first course of induction
Time frame: 1 month
CR/CRh rates in newly diagnosed AML patients across different patient subgroups
CR/CRh rates in newly diagnosed AML patients across different groups are defined based on prognostic characteristics including age at randomization , risk category according to ELN 2022 recommendations, as well as specific AML genotypes
Time frame: 2 months
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Started Sep 2022 (actual). Primary completion is estimated for Mar 2029, 78 months after the start.
Of 78 non-industry phase 3 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 87 months of starting (the median), counting those still running; a quarter within 66 and three quarters within 111. This study's planned 78 months is below that.
Counting every sponsor, half of 120 studies reached it within 74 months; a quarter within 39 and three quarters within 99.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Venetoclax