TrialSignal
Clinical trial intelligence report
Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT07075016-Jul 28, 2026
NCT ID
NCT07075016
Status
RECRUITING
Phase
Phase 3
Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Executive brief
Investment-Ready Snapshot
The trial investigates the efficacy of combining venetoclax with the standard treatment of ivosidenib and azacitidine in patients with newly diagnosed IDH1-mutated AML or MDS/AML who are ineligible for intensive chemotherapy. The market for AML treatments is competitive, with several existing therapies, including targeted agents and hypomethylating agents. Should the combination therapy demonstrate improved outcomes, it could capture significant market share, particularly among older patients and those with comorbidities who are unable to tolerate intensive chemotherapy. The collaboration with multiple European study groups enhances the trial's credibility and recruitment potential, positioning it favorably in the competitive landscape.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT07075016
Indication
Acute Myeloid Leukemia
Modality
small molecule
Target
IDH1 mutation in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) with acute myeloid leukemia (MDS/AML)
Intervention
Venetoclax 400, Placebo
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.