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Anti-metabolites

CPX-351 + Ivosidenib for Acute Myeloid Leukemia/Myelodysplastic Syndrome

Phase 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

Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

Creatinine clearance >= 30 ml/min based on the Cockcroft-Gault equation

Must not have

Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications

Patients who have previously received either ivosidenib or CPX-351

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well CPX-351 and ivosidenib work in treating patients with leukemia or myelodysplastic syndrome that has an IDH1 mutation.

Who is the study for?

This trial is for adults with acute myeloid leukemia or high-risk myelodysplastic syndrome that have an IDH1 mutation. Participants can be new to treatment or have relapsed and must be fit enough for intensive chemotherapy (ECOG <=2). They should not have severe heart issues, a history of certain brain infections, or excessive prior anthracycline exposure. Women must avoid pregnancy and men must refrain from donating sperm during the trial.

What is being tested?

The study is testing CPX-351 (a chemo drug combo) alongside Ivosidenib in patients with specific genetic changes in their cancer cells. The goal is to see if this combination helps control the growth of cancer cells better than current treatments by blocking enzymes needed for cell growth.

What are the potential side effects?

Possible side effects include typical chemotherapy-related issues like fatigue, nausea, hair loss, increased risk of infection due to low blood counts, as well as potential liver problems indicated by elevated bilirubin levels. Ivosidenib may cause changes in heart rhythm or other organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My kidneys are functioning well enough to clear waste.

Exclusion Criteria

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

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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 CPX-351.

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I have a history of PML.

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I don't have major side effects from previous cancer treatments.

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I do not have any severe health issues that could make the study treatment unsafe for me.

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I do not have severe heart failure, unstable chest pain, or a weak heart pump.

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I have received a high dose of anthracycline drugs, or a lower dose if I had radiation therapy to the chest area.

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I have been diagnosed with acute promyelocytic leukemia.

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

Overall response rate (ORR)

Secondary study objectives

Duration of response

Event-free survival

Incidence of adverse events

+1 more

Other study objectives

Minimal residual disease (MRD) status

Side effects data

From 2020 Phase 2 trial • 56 Patients • NCT02286726

25%

Febrile Neutropenia

21%

Neutropenic Fever

17%

Lung Infection

17%

Sepsis

13%

Insomnia

Pericardial Effusion

Infection

Hypertension

Pleural Effusion

Pancreatitis

Intracranial Hemorrhage

Cardiac Disorders

Fever

Joint Effusion

Alanine aminotransferase Increase

Anxiety

Blood Bilirubin Increase

Acute Coronary Syndrome

Respiratory Failure

Multi-Organ Failure

100%

80%

60%

40%

20%

Study treatment Arm

Arm II (Intermediate-dose (75 Units/m^2) CPX-351)

Arm III (Standard-dose (100 Units/m^2) CPX-351)

Arm I (Lower-dose (50 Units/m^2) CPX-351)

Awards & Highlights

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 (CPX-351, ivosidenib)Experimental Treatment2 Interventions

INDUCTION: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and ivosidenib PO QD on days 1-28. Patients who do not achieve complete remission may receive a second cycle of induction therapy in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission proceed to consolidation. CONSOLIDATION: Patients receive CPX-351 IV over 90 minutes on days 1 and 3, and ivosidenib PO QD on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive ivosidenib PO QD for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients who are experiencing clinical benefit and who have not experienced excessive toxicity after completion of 2 years of maintenance may be eligible to continue therapy after discussion with the principal investigator.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ivosidenib

2023

Completed Phase 2

~30

Liposome-encapsulated Daunorubicin-Cytarabine

2017

Completed Phase 2

~170