Acute Myeloid LeukemiaPhase 1NCT05155709
A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.
A Phase 1 study testing siremadlin, venetoclax and azacitidine in people with Acute Myeloid Leukemia, run by Novartis Pharmaceuticals at 10 sites in 7 countries.
Trial summary
A study of siremadlin in combination with venetoclax plus azacitidine in adult participants with AML who are ineligible for chemotherapy. The primary purpose of this study was to assess whether siremadlin in combination with venetoclax plus azacitidine can enhance the clinical response in unfit AML participants… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- siremadlin, venetoclax and azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 17 May 2022to 17 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at the date of signing the informed consent form (ICF):
- Arm 1 and Arm 2: ≥ 18 years
- Participants diagnosed with AML based on WHO 2016 classification (Arber et al 2016) who are ineligible for standard induction chemotherapy and:
- Arm 1 : have received at least 2 cycles and not more than 4 cycles of first-line venetoclax plus azacitidine treatment and have not achieved a CR, CRi, CRh or MLFS.
- Arm 2 : newly diagnosed AML with adverse genetic risk stratification (according to ELN 2022) (except TP53 mutation positive participants).
- Participant (in both arms) must be considered ineligible for standard of care intensive induction chemotherapy defined by the following:
Show all 13Show fewer
- 75 years of age; OR
- 18 to 74 years of age with at least one of the following co-morbidities: Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3; Cardiac history of congestive heart failure (CHF) requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina; DLCO ≤ 65% or FEV1 ≤ 65%.
- Participants must have an ECOG performance status:
- 0 to 2 for participants ≥ 75 years of age. OR 0 to 3 for participants ≥ 18 to 74 years of age.
- WBC < 25x109/L
- AST and ALT ≤ 3 × ULN
- Estimated Glomerular Filtration Rate (eGFR)≥ 60 mL/min/1.73 m2
Who cannot join
- Prior exposure to MDM2-inhibitor therapy at any time.
- Participants with TP53 mutation positive.
- Participants with del17p.
- Participants with AML-M3 / APL (Acute promyelocytic leukemia) with PML-RARA (Promyelocytic leukemia/retinoic acid receptor alpha) or with AML secondary to Down's syndrome.
- Participants treated with FLT3 inhibitors for AML indication are not eligible.
- Participants who require treatment with moderate or strong CYP3A4 inducers within 14 days prior to starting study treatment, or are expected to receive moderate or strong CYP3A4 inducers during the entire study
- Participants who require treatment with substrates of CYP3A4/5 with a narrow therapeutic index.
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
United States2 sites
Texas Oncology Sammons Cancer Center
Dallas, Texas, 78246
Oregon Health Sciences University
Portland, Oregon, 97239
Israel2 sites
Novartis Investigative Site
Beersheba, 8457108
Novartis Investigative Site
Jerusalem, 9112001
Malaysia2 sites
Novartis Investigative Site
Alor Star, Kedah, 05460
Novartis Investigative Site
Kuala Selangor, 68000
Turkey (Türkiye)1 site
Novartis Investigative Site
Izmir, Balcova, 35340
About this study
Official title: A Phase Ib/II Open Label Dose Confirmation, Proof of Concept Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Unfit Adult AML Participants Who Responded Sub-optimally to First-line Venetoclax Plus Azacitidine Treatment and in Participants With Newly Diagnosed Unfit AML Presenting With High-risk Clinical Features
A study of siremadlin in combination with venetoclax plus azacitidine in adult participants with AML who are ineligible for chemotherapy.
The primary purpose of this study was to assess whether siremadlin in combination with venetoclax plus azacitidine can enhance the clinical response in unfit AML participants without unacceptable levels of treatment-emergent toxicities.
Read the detailed description
The recommended dose of siremadlin in combination with venetoclax plus azacitidine was to be determined to be explored further in the expansion phase and the preliminary efficacy in achieving Complete Remission (CR) evaluated in participants who responded sub-optimally to first-line venetoclax plus azacitidine treatment.
The study was planned to be conducted in two parts. The primary purpose of Part 1 (Safety Run- in) was to rule out excessive toxicity of siremadlin when administered in combination with venetoclax plus azacitidine while the primary purpose of Part 2 (Expansion) was to evaluate the preliminary efficacy of siremadlin when combined with venetoclax plus azacitidine in the respective patient population.
The study treatment (siremadlin in combination with venetoclax plus azacitidine) was administered in cycles with a planned duration of 28 days for each cycle and would continue until the participants experienced disease progression/relapse or unacceptable toxicity.
The initial enrollment plan and safety review was as follow:
- In the Safety run-in part, 9-15 participants were planned to be enrolled in each arm. Approximately 3-6 participants were planned to be enrolled at the starting dose level of siremadlin in combination with venetoclax plus azacitidine in both arms independently. Provided the starting dose level was determined to be safe, approximately 6-9 additional participants were planned to be enrolled at dose level +1. Safety review meetings were planned to take place involving participating investigators and the Sponsor Team to make decisions regarding siremadlin dose and determine the recommended dose for expansion.
- Approximately 26 patients were planned to be treated at the recommended dose in the expansion part.
In the safety run-(Part 1) 10 sites in 7 countries enrolled 14 patients.
After enrolling 14 patients (6 patients in Arm 1 and 8 patients in Arm 2), Novartis took the decision to put the enrollment in permanent halt and terminate the siremadlin program. For that reason, the enrollment in Part 2 (expansion phase) did not open. The Novartis decision was not driven by any safety concerns.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- siremadlin, venetoclax, azacitidine
- Keywords
- Acute myeloid leukemia, AML, Azacitidine, venetoclax, TP53, MDM2, siremadlin, HDM201, unfit AML, newly diagnosed unfit AML, presenting with high-risk clinical features
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
siremadlinDrug
Also called HDM201
Siremadlin is a capsule taken orally once a day (QD) and comes in 10 mg, 20 mg and 30 mg strengths
venetoclaxDrug
Venetoclax is a tablet taken orally once a day (QD) and comes in 10 mg, 50 mg and 100 mg strengths.
azacitidineDrug
Azacitidine is a powder for suspension for injection or powder for solution for infusion taken intravenously or subcutaneously comes in 100 mg but was administered according to standard local clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Adult participants with unfit AML who responded sub-optimally to standard of care | Experimental | Unfit adult participants with unfit AML who responded sub-optimally to at least 2 and not more than 4 cycles of first-line venetoclax plus azacitidine therapy. Siremadlin was adminstered at a dose of 20 mg QD which could be increased based on toxicities; venetoclax was administered at 400 mg once daily and azacitidine was administered at 75 mg/m^2. Receives: Drug: siremadlin; Drug: venetoclax; Drug: azacitidine |
| Arm 2: Adult participants with newly diagnosed unfit AML with high risk clinical features | Experimental | Adult participants with unfit AML who were newly diagnosed and presenting with high-risk clinical features (which related to factors conferring to a low likelihood of response to venetoclax plus azacitidine) and with adverse genetic risk stratification (according to ELN 2022) (Except TP53 mutation positive participants). Siremadlin was administered at a dose of 20 mg QD which could be increased based on toxicities; venetoclax was administered at 400 mg once daily and azacitidine was administered at 75 mg/m^2. Receives: Drug: siremadlin; Drug: venetoclax; Drug: azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with Dose Limiting Toxicities (DLTs) as per investigator assessment reported during the first cycle (separately in Arm 1 & Arm 2)
A dose-limiting toxicity (DLT) is defined as an adverse event (AE) or abnormal laboratory value considered by the Investigator to be at least possibly related to siremadlin as a single contributor or in combination with other component(s) of study treatment that occurs beginning the first day of siremadlin dosing in the study until end of cycle 1.
Measured: From Cycle 1 Day 1 to Cycle 1 Day 28 (28 days)
Percentage of participants achieving a complete remission (CR) rate at recommended dose for expansion (RDE) as per investigator assessment (Arm 1 only)
Assessed by CR rate. CR rate is defined as the percentage of participants with best overall response of complete remission (CR) as per investigator assessment.
Measured: At least 7 cycles (196 days)
Secondary outcomes (12)
Percentage of participants achieving complete remission (CR) as per Investigator assessment (Arm 2 only)
Assessed by CR rate. CR rate is defined as the percentage of participants with best overall response of complete remission (CR) as per investigator assessment.
Measured: up to 3 years
Time from date of the first documented CR to the date of the first documented relapse or death due to any cause, whichever occurs first (Arm 1 and Arm 2 separately)
Duration of CR is defined as time from the date of the first documented CR to the date of first documented relapse or death due to any cause, whichever occurs first.
Assessment of duration of CR in participants who achieved a CR.
This endpoint was not analyzed since the recommended dose was not determined due to early termination.
Measured: up to 3 years
Percentage of participants achieving CR or complete remission with partial hematological recovery (CRh) (Arm 1 & 2)
Assessed by CR/CRh rate. CR/CRh rate is defined as the percentage of participants with best overall response of either CR or CRh as per investigator assessment.
Measured: up to 3 years
Percentage of participants achieving CR or complete remission with incomplete hematological recovery (CRi) (Arm 1 and Arm 2)
Assessed by CR/CRi rate. CR/CRi rate is defined as the percentage of participants with best overall response of either CR or CRi as per investigator assessment.
Measured: up to 3 years
Time from the date of the first documented CR/CRh to the date of first documented relapse or death due to any cause, whichever occurs first (Arm 1 and Arm 2 separately)
Assessed by duration of CR/CRh. Duration of CR/CRh is defined as time from the date of the first documented CR/CRi to the date of first documented relapse or death due to any cause, whichever occurs first.
This endpoint will not be analyzed since the recommended dose was not determined due to early termination.
Measured: up to 3 years
Time from the date of the first documented CR/CRi to the date of first documented relapse or death due to any cause, whichever occurs first (Arm 1 and Arm 2 separately)
Assessed by duration of CR/CRi. Duration of CR/CRi is defined as time from the date of the first documented CR/CRi to the date of first documented relapse or death due to any cause, whichever occurs first.
This endpoint will not be analyzed since the recommended dose was not determined due to early termination
Measured: up to 3 years
Overall Survival (OS) (Arm 1 and Arm 2 separately)
OS is the time from start of treatment to death due to any cause.
This endpoint was not analyzed since the recommended dose was not determined due to early termination.
Measured: up to 3 years
Early mortality (Arm 1 and Arm 2)
Early mortality is the percentage of participants who died due to any cause from start of treatment until 30- and 60-day.
Measured: 30 days & 60 days from start of study treatment
Pharmacokinetic (PK) parameters: AUCs of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)
AUC0-t: The area under the concentration vs. time Curve (AUC) from time zero to specified time point.
AUClast is the AUC from time zero to the last quantifiable concentration point (last) (mass x time x volume -1).
AUCtau is the AUC to the end of the dosing interval as when possible PK samples will be collected up to 24 h postdose for siremadlin and venetoclax. Steady-state will be assumed on Day 5 (AUCtau, ss) in case of continuous dosing.
Measured: up to 3 years
PK parameter: Cmax of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)
To characterize the PK of siremadlin, venetoclax and azacitidine administered in combination in each arm. Cmax is the maximum (peak) observed plasma, blood, serum or other body fluid drug concentration following drug administration (mass x volume -1)
Measured: up to 3 years
PK parameter: Tmax of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)
PK parameter Tmax and concentration vs time profiles of siremadlin, venetoclax and azacitidine. Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after drug administration (time).
Measured: up to 3 years
Percentage of CR- Measurable Residual Disease (MRD) negative overall and in participants achieving a CR, CR/CRh, and CR/CRi (Arm 1 and Arm 2)
Assessed by MRD-negativity rate. MRD negativity rate is defined as the percentage of participants with a CR/CRh/CRi-MRD negative sample.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start17 May 2022
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
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 Novartis PharmaceuticalsThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155709
- Sponsor's protocol ID
- CHDM201I12201
- Other IDs
- 2021-001165-21
- Status last verified
- Apr 2026
- First submitted
- 20 Oct 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Open Label Dose Confirmation, Proof of Concept Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Unfit Adult AML Participants Who Responded Sub-optimally to First-line Venetoclax Plus Azacitidine Treatment and in Participants With Newly Diagnosed Unfit AML Presenting With High-risk Clinical Features
- ClinicalTrials.gov ID
- NCT05155709
- Acronym / sponsor ID
- CHDM201I12201
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia, AML, Azacitidine, venetoclax, TP53, MDM2, siremadlin, HDM201
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 14 Dec 2021 (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.
A study of siremadlin in combination with venetoclax plus azacitidine in adult participants with AML who are ineligible for chemotherapy.
The primary purpose of this study was to assess whether siremadlin in combination with venetoclax plus azacitidine can enhance the clinical response in unfit AML participants without unacceptable levels of treatment-emergent toxicities.
Detailed description
The recommended dose of siremadlin in combination with venetoclax plus azacitidine was to be determined to be explored further in the expansion phase and the preliminary efficacy in achieving Complete Remission (CR) evaluated in participants who responded sub-optimally to first-line venetoclax plus azacitidine treatment.
The study was planned to be conducted in two parts. The primary purpose of Part 1 (Safety Run- in) was to rule out excessive toxicity of siremadlin when administered in combination with venetoclax plus azacitidine while the primary purpose of Part 2 (Expansion) was to evaluate the preliminary efficacy of siremadlin when combined with venetoclax plus azacitidine in the respective patient population.
The study treatment (siremadlin in combination with venetoclax plus azacitidine) was administered in cycles with a planned duration of 28 days for each cycle and would continue until the participants experienced disease progression/relapse or unacceptable toxicity.
The initial enrollment plan and safety review was as follow:
- In the Safety run-in part, 9-15 participants were planned to be enrolled in each arm. Approximately 3-6 participants were planned to be enrolled at the starting dose level of siremadlin in combination with venetoclax plus azacitidine in both arms independently. Provided the starting dose level was determined to be safe, approximately 6-9 additional participants were planned to be enrolled at dose level +1. Safety review meetings were planned to take place involving participating investigators and the Sponsor Team to make decisions regarding siremadlin dose and determine the recommended dose for expansion.
- Approximately 26 patients were planned to be treated at the recommended dose in the expansion part.
In the safety run-(Part 1) 10 sites in 7 countries enrolled 14 patients.
After enrolling 14 patients (6 patients in Arm 1 and 8 patients in Arm 2), Novartis took the decision to put the enrollment in permanent halt and terminate the siremadlin program. For that reason, the enrollment in Part 2 (expansion phase) did not open. The Novartis decision was not driven by any safety concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Adult participants with unfit AML who responded sub-optimally to standard of care | Experimental | Drug: siremadlin, Drug: venetoclax, Drug: azacitidineUnfit adult participants with unfit AML who responded sub-optimally to at least 2 and not more than 4 cycles of first-line venetoclax plus azacitidine therapy. Siremadlin was adminstered at a dose of 20 mg QD which could be increased based on toxicities; venetoclax was administered at 400 mg once daily and azacitidine was administered at 75 mg/m^2. |
| Arm 2: Adult participants with newly diagnosed unfit AML with high risk clinical features | Experimental | Drug: siremadlin, Drug: venetoclax, Drug: azacitidineAdult participants with unfit AML who were newly diagnosed and presenting with high-risk clinical features (which related to factors conferring to a low likelihood of response to venetoclax plus azacitidine) and with adverse genetic risk stratification (according to ELN 2022) (Except TP53 mutation positive participants). Siremadlin was administered at a dose of 20 mg QD which could be increased based on toxicities; venetoclax was administered at 400 mg once daily and azacitidine was administered at 75 mg/m^2. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age at the date of signing the informed consent form (ICF):
- Participants diagnosed with AML based on WHO 2016 classification (Arber et al 2016) who are ineligible for standard induction chemotherapy and:
- Participant (in both arms) must be considered ineligible for standard of care intensive induction chemotherapy defined by the following:
- Participants must have an ECOG performance status:
- 0 to 2 for participants ≥ 75 years of age. OR 0 to 3 for participants ≥ 18 to 74 years of age.
Key exclusion criteria (7 listed)
- Prior exposure to MDM2-inhibitor therapy at any time.
- Participants with TP53 mutation positive.
- Participants with del17p.
- Participants with AML-M3 / APL (Acute promyelocytic leukemia) with PML-RARA (Promyelocytic leukemia/retinoic acid receptor alpha) or with AML secondary to Down's syndrome.
- Participants treated with FLT3 inhibitors for AML indication are not eligible.
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 |
|---|---|---|
| siremadlinAlso: HDM201Siremadlin is a capsule taken orally once a day (QD) and comes in 10 mg, 20 mg and 30 mg strengths | Drug | Arm 1: Adult participants with unfit AML who responded sub-optimally to standard of care, Arm 2: Adult participants with newly diagnosed unfit AML with high risk clinical features |
| venetoclaxVenetoclax is a tablet taken orally once a day (QD) and comes in 10 mg, 50 mg and 100 mg strengths. | Drug | Arm 1: Adult participants with unfit AML who responded sub-optimally to standard of care, Arm 2: Adult participants with newly diagnosed unfit AML with high risk clinical features |
| azacitidineAzacitidine is a powder for suspension for injection or powder for solution for infusion taken intravenously or subcutaneously comes in 100 mg but was administered according to standard local clinical practice. | Drug | Arm 1: Adult participants with unfit AML who responded sub-optimally to standard of care, Arm 2: Adult participants with newly diagnosed unfit AML with high risk clinical features |
Primary outcome
Percentage of participants with Dose Limiting Toxicities (DLTs) as per investigator assessment reported during the first cycle (separately in Arm 1 & Arm 2)
Time frame: From Cycle 1 Day 1 to Cycle 1 Day 28 (28 days)
A dose-limiting toxicity (DLT) is defined as an adverse event (AE) or abnormal laboratory value considered by the Investigator to be at least possibly related to siremadlin as a single contributor or in combination with other component(s) of study treatment that occurs beginning the first day of siremadlin dosing in the study until end of cycle 1.
Percentage of participants achieving a complete remission (CR) rate at recommended dose for expansion (RDE) as per investigator assessment (Arm 1 only)
Time frame: At least 7 cycles (196 days)
Assessed by CR rate. CR rate is defined as the percentage of participants with best overall response of complete remission (CR) as per investigator assessment.
12 secondary outcomes
Percentage of participants achieving complete remission (CR) as per Investigator assessment (Arm 2 only)
Time frame: up to 3 years
Time from date of the first documented CR to the date of the first documented relapse or death due to any cause, whichever occurs first (Arm 1 and Arm 2 separately)
Time frame: up to 3 years
Percentage of participants achieving CR or complete remission with partial hematological recovery (CRh) (Arm 1 & 2)
Time frame: up to 3 years
Percentage of participants achieving CR or complete remission with incomplete hematological recovery (CRi) (Arm 1 and Arm 2)
Time frame: up to 3 years
Time from the date of the first documented CR/CRh to the date of first documented relapse or death due to any cause, whichever occurs first (Arm 1 and Arm 2 separately)
Time frame: up to 3 years
Time from the date of the first documented CR/CRi to the date of first documented relapse or death due to any cause, whichever occurs first (Arm 1 and Arm 2 separately)
Time frame: up to 3 years
Overall Survival (OS) (Arm 1 and Arm 2 separately)
Time frame: up to 3 years
Early mortality (Arm 1 and Arm 2)
Time frame: 30 days & 60 days from start of study treatment
Pharmacokinetic (PK) parameters: AUCs of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)
Time frame: up to 3 years
PK parameter: Cmax of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)
Time frame: up to 3 years
PK parameter: Tmax of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)
Time frame: up to 3 years
Percentage of CR- Measurable Residual Disease (MRD) negative overall and in participants achieving a CR, CR/CRh, and CR/CRi (Arm 1 and Arm 2)
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing siremadlin, venetoclax and azacitidine in people with Acute Myeloid Leukemia, run by Novartis Pharmaceuticals at 10 sites in 7 countries.
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 13 inclusion and 7 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: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Israel, Malaysia, Hong Kong, Hungary and 2 more countries. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with Dose Limiting Toxicities (DLTs) as per investigator assessment reported during the first cycle (separately in Arm 1 & Arm 2) (time frame: From Cycle 1 Day 1 to Cycle 1 Day 28 (28 days)). The study lists 2 primary outcomes in all. 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 7 May 2026.