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IDH1 Inhibitor

Ivosidenib + Venetoclax +/- Azacitidine for Leukemia

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.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

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 more

Other study objectives

Peripheral blood and bone marrow aspirate samples

Plasma concentrations and pharmacokinetic parameter

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

0 / 10Eligibility criteria met