At a glance
ClinicalIndex Comparison Record- ✓Age greater than 18 years
- ✓ECOG performance status less than 2
- ✓IDH1-R132 mutated disease
- ✓Relapsed/refractory AML or treatment-naïve AML ineligible for standard induction chemotherapy
- ✕Known allergy or hypersensitivity to ivosidenib or venetoclax
- ✕Prior receipt of ivosidenib or venetoclax
- ✕Uncontrolled clinically significant medical condition including infection, laboratory abnormality, or psychiatric illness
- ✕Concomitant chemotherapeutic or anti-leukemic agents (with exceptions for intrathecal chemotherapy, hydroxyurea, or cytarabine)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase Ib/II Investigator Initiated Study of the IDH1-Mutant Inhibitor Ivosidenib (AG120) With the BCL2 Inhibitor Venetoclax +/- Azacitidine in IDH1-Mutated Hematologic Malignancies
In Brief
A Phase 2 clinical trial evaluating Azacitidine, Ivosidenib, and 1 other intervention for Acute Myeloid Leukemia and 5 related conditions. Currently recruiting, targeting 96 participants across 4 sites.
Detailed Summary
This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.
Study Details
Timeline
Interventions
Given IV or SC
Given PO
Given PO