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DNA Methyltransferase Inhibitor

Siremadlin + Venetoclax + Azacitidine for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have specific ECOG performance status, WBC count, liver enzyme levels, and kidney function
Participants diagnosed with AML based on WHO 2016 classification who are ineligible for standard induction chemotherapy and have specific treatment history criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat AML in adults who are not eligible for chemotherapy.

Who is the study for?
Adults with Acute Myeloid Leukemia (AML) who can't have standard chemotherapy are eligible. They must be over 18, not have achieved complete remission after 2-4 cycles of venetoclax plus azacitidine, or be newly diagnosed with a high genetic risk but without TP53 mutations. Exclusions include certain heart and lung conditions, poor kidney function, and those taking drugs that interact poorly with the trial medications.Check my eligibility
What is being tested?
The study is testing siremadlin combined with venetoclax and azacitidine in AML patients ineligible for chemotherapy. It's designed to see if this combination helps when standard treatments aren't an option due to health risks or previous treatment failure.See study design
What are the potential side effects?
Potential side effects may include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems, liver issues indicated by elevated enzymes, fatigue, and possible drug interactions affecting heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My physical ability, blood cell count, liver, and kidney functions meet the study's requirements.
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I have AML and can't undergo standard chemotherapy due to my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants treated at the recommended dose for expansion, achieving a complete remission (CR) as per investigator assessment (Arm 1 only)
Percentage of participants with Dose Limiting Toxicities (DLTs) as per investigator assessment reported during the first cycle (separately in Arm 1 & Arm 2)
Secondary outcome measures
PK parameter: Cmax of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)
PK parameter: Tmax of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)
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)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Newly diagnosed unfit adult participants with high-risk AMLExperimental Treatment3 Interventions
Unfit adult participants with newly diagnosed AML and with adverse genetic risk stratification (according to ELN 2022)(Except TP53 mutation positive participants).
Group II: Arm 1: Unfit adult participants with AML who responded sub-optimally to standard of careExperimental Treatment3 Interventions
Unfit adult participants with AML who responded sub-optimally to at least 2 and not more than 4 cycles ( 1 cycle=28 days) of first-line venetoclax plus azacitidine therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
venetoclax
2021
Completed Phase 2
~750
azacitidine
2005
Completed Phase 3
~1740

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,339 Total Patients Enrolled

Media Library

Azacitidine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05155709 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Arm 1: Unfit adult participants with AML who responded sub-optimally to standard of care, Arm 2: Newly diagnosed unfit adult participants with high-risk AML
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT05155709 — Phase 1 & 2
Azacitidine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05155709 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial only testing for subjects under the age of 55?

"According to the eligibility requirements published for this trial, patients must be aged 18-99. There are 491 other trials available for patients that are under 18 and 1613 studies listed for patients over 65."

Answered by AI

How many research facilities are handling this trial's data?

"Right now, there are 6 sites where this clinical trial is enrolling patients. They can be found in cities like Portland and Houston as well as Longmont and 6 other locations. If you want to take part in the study, try to choose a location that's close to minimize travel."

Answered by AI

To your knowledge, what other research has been conducted with siremadlin?

"At present, 354 separate clinical trials are underway to study siremadlin. Of these, 55 are in Phase 3. While some of the trials for siremadlin are based in Edmonton, Alberta, there are 11349 locations running studies for siremadlin globally."

Answered by AI

Are you looking for more participants in this research?

"Yes, this information can be found on the website clinicaltrials.gov. The study was created on 5/17/2022 and was last edited on 10/25/2022."

Answered by AI

Siremadlin has been used for what indications most often?

"Siremadlin is a common induction chemotherapy medication, but it can also be used to treat other blood disorders like refractory anemias, leukemia, and myelocytic acute."

Answered by AI

What are the goals that researchers are hoping to achieve with this clinical trial?

"The primary objective of this trial, which will be assessed over a period of 196 days, is to determine the percentage of participants with dose limiting toxicities. Secondary outcomes include the percentage of participants treated at the recommended expansionary dose who achieve complete remission and the proportion of participants achieving CR or complete remission with partial/incomplete hematological recovery. Additionally, the trial hopes to assess the effect of siremadlin in combination with venetoclax plus azacitidine on measurable residual disease."

Answered by AI

Can I join this clinical trial?

"Myeloid leukemia patients that are between 18-99 years old qualify for this study, of which around 55 are needed."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.
2022. "A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05155709.
~1 spots leftby May 2024
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