Ivosidenib and Venetoclax for IDH1-Mutated Blood Cancers
This study is looking at how safe and effective a combination of medicines is for people with certain blood cancers (hematologic malignancies) that have a specific genetic change called an IDH1 mutation. The medicines being tested are ivosidenib and venetoclax, given with or without another medicine called azacitidine. Ivosidenib and venetoclax may work by blocking enzymes that cancer cells need to grow. Azacitidine is a chemotherapy drug that helps stop cancer cell growth. The goal is to see if adding azacitidine makes the treatment work better. To join, you must be over 18, have an IDH1 mutation, and have certain types of relapsed/refractory acute myeloid leukemia (AML) or newly diagnosed AML if you can't have standard chemotherapy. The study will measure how many people respond to the treatment and any side effects over up to three years. The current status of this study is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to find the best dose and measure how many people respond to the treatment.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track overall response and side effects for up to three years, and dose-limiting toxicity for up to 56 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
At a glance
Conditions
NCT03471260
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohiostudy coordinator listed
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusettsstudy coordinator listed
Recruiting
M D Anderson Cancer Center
Houston, Texasstudy coordinator listed
Recruiting
Oregon Health and Science University
Portland, Oregonstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Courtney DiNardo, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Overall response rate (ORR)Up to 3 years
Defined as complete response (CR), CR with incomplete blood count recovery (CRi), morphologic leukemia-free state (MLFS), and partial response (PR) based on revised International Working Group (IWG) response criteria. Analysis will be performed for enrolled subjects.
- Incidence of adverse eventsUp to 3 years
Will be collected using leukemia adverse event guidelines.
- Dose-limiting toxicityUp to 56 days
Defined as any grade 3 or 4, clinically significant non-hematologic adverse event or abnormal laboratory value.