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IDH1 Inhibitor
Ivosidenib + Venetoclax +/- Azacitidine for Leukemia
Portland, OR
Phase 1 & 2
Recruiting
Led By Courtney DiNardo
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years
ECOG performance status of < 2
Must not have
Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, IUD, and double barrier methods (for example a condom in combination with a spermicide)
Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial is testing the side effects and best dose of two drugs, venetoclax and ivosidenib, when given together with or without a third drug, azacitidine. The drugs may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Who is the study for?
This trial is for patients with IDH1-mutated blood cancers like AML, MDS, or MPN who are either treatment-naive and ineligible for standard chemotherapy or have relapsed/refractory disease. Participants must be in stable condition with acceptable organ function and agree to contraception. Those previously treated with ivosidenib/venetoclax, active infections (HBV/HCV/HIV), uncontrolled medical conditions, severe allergies to study drugs, or on certain medications are excluded.Check my eligibility
What is being tested?
The trial examines the effectiveness of combining venetoclax and ivosidenib with or without azacitidine in treating hematologic malignancies. It aims to determine the best dose while assessing side effects when these drugs work together compared to using just venetoclax and ivosidenib.See study design
What are the potential side effects?
Potential side effects include risks associated with blocking enzymes needed by cancer cells which may affect normal cell growth as well. Azacitidine as a chemotherapy drug can cause cell death leading to symptoms such as fatigue, nausea, bruising due to low blood counts, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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I can do most of my daily activities without help.
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My kidneys work well enough, with a creatinine clearance over 30 ml/min.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, using effective birth control, or not of childbearing potential.
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I do not have severe stomach or metabolic issues affecting medication absorption.
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I have previously been treated with ivosidenib or venetoclax.
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I am not taking strong medication inducers like rifampin or St. John's wort within 3 days of starting the study.
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I am allergic to ivosidenib or venetoclax.
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I am currently being treated for another cancer.
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I do not have active hepatitis B, hepatitis C, or HIV.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose-limiting toxicity
Incidence of adverse events
Overall response rate (ORR)
Secondary study objectives
Duration of response
Event-free survival
Overall survival
+1 moreOther study objectives
Peripheral blood and bone marrow aspirate samples
Plasma concentrations and pharmacokinetic parameter
Side effects data
From 2024 Phase 2 trial • 528 Patients • NCT0349852138%
Anaemia
23%
Nausea
21%
Fatigue
15%
Asthenia
14%
Thrombocytopenia
12%
Neutropenia
12%
Constipation
11%
Pyrexia
10%
Abdominal pain
10%
Platelet count decreased
9%
Diarrhoea
9%
Neutrophil count decreased
9%
Vomiting
8%
Oedema peripheral
8%
Back pain
7%
White blood cell count decreased
7%
Weight decreased
7%
Hyponatraemia
5%
Leukopenia
5%
Hypothyroidism
5%
Decreased appetite
5%
Hypoalbuminaemia
5%
COVID-19
5%
Hypomagnesaemia
5%
Bone pain
5%
Insomnia
4%
Sepsis
3%
Atrial fibrillation
2%
Dyspnoea
2%
Renal failure
1%
Haemoptysis
1%
Gastroenteritis viral
1%
Pleural effusion
1%
Wrist fracture
1%
Hydronephrosis
1%
Wound infection
1%
Urosepsis
1%
Urinary tract infection
1%
Peritonitis
1%
Pneumonia
1%
Cardiac arrest
1%
Anxiety
1%
Delirium
1%
Cardio-respiratory arrest
1%
Respiratory tract infection
1%
Respiratory tract infection fungal
1%
Circulatory collapse
1%
Tumour associated fever
1%
Myalgia
1%
Cardiac failure chronic
1%
Pain
1%
Cerebral haemorrhage
1%
Febrile neutropenia
1%
Anal abscess
1%
Hip fracture
1%
Death
1%
General physical health deterioration
1%
Ascites
1%
Haemorrhoidal haemorrhage
1%
Abdominal sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Category 2
Molecularly-Guided Therapy MGT) Category 1
Chemotherapy Category 1
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (venetoclax, ivosidenib, azacitidine)Experimental Treatment3 Interventions
Patients receive venetoclax PO daily on days 1-14. Patients also receive ivosidenib PO daily on days 15-28 of cycle 1 and days 1-28 of subsequent cycles. Patients may also receive azacitidine IV over 30-60 minutes or SC on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
Ivosidenib
FDA approved
Venetoclax
FDA approved
Find a Location
Closest Location:Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OH· 129 miles
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,099 Previous Clinical Trials
1,812,459 Total Patients Enrolled
Courtney DiNardoPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
552 Total Patients Enrolled
Courtney DiNardo, MDPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
552 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have AML or a related condition and cannot have standard chemotherapy.My liver is functioning well, according to my recent tests.I haven't had cancer treatment in the last 7 days.I am not pregnant, using effective birth control, or not of childbearing potential.My cancer has a specific IDH1 mutation.My white blood cell count is above 25 x 10⁹/L.I do not have severe stomach or metabolic issues affecting medication absorption.I have previously been treated with ivosidenib or venetoclax.I am not on other cancer drugs, except for specific exceptions.I am older than 18 years.I can do most of my daily activities without help.My kidneys work well enough, with a creatinine clearance over 30 ml/min.I agree not to have unprotected sex or donate sperm for 90 days after my last dose.I am not taking strong medication inducers like rifampin or St. John's wort within 3 days of starting the study.I am allergic to ivosidenib or venetoclax.I am currently being treated for another cancer.I don't have active graft-versus-host disease after a stem cell transplant.I do not have active hepatitis B, hepatitis C, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (venetoclax, ivosidenib, azacitidine)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.