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Anti-tumor antibiotic, Anti-metabolites

Liposomal Daunorubicin-Cytarabine + Venetoclax for Acute Myeloid Leukemia

Phase 2

Recruiting

Led By Tapan M Kadia

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

For the dose expansion cohort A (relapsed/refractory [R/R] AML): Patients >= 18 years of age with a diagnosis of relapsed and/or refractory AML will be eligible

For the dose expansion cohort B (de novo AML): Patients >= 18 years to 69 years of age; patients in this cohort must have received no prior therapy for AML

Must not have

Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided

Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well liposome-encapsulated daunorubicin-cytarabine and venetoclax work in treating people with acute myeloid leukemia.

Who is the study for?

Adults diagnosed with Acute Myeloid Leukemia that's untreated, not responding to treatment, or has returned after treatment. Participants must be over 18 (up to 69 for certain groups), have acceptable organ function and performance status, and women of childbearing age must test negative for pregnancy. Those with CNS leukemia, prior CPX-351 or venetoclax use (except specific cases), uncontrolled illnesses, known hypersensitivity to the drugs used, or unwillingness to use contraception are excluded.

What is being tested?

The trial is testing a combination of chemotherapy agents: liposome-encapsulated daunorubicin-cytarabine and venetoclax in patients with Acute Myeloid Leukemia. It aims to see how well these drugs work together in different scenarios such as relapsed/refractory AML or newly diagnosed patients.

What are the potential side effects?

Potential side effects include damage to organs from chemotherapy like heart problems; blood disorders; increased risk of infections due to lowered immunity; nausea and vomiting; hair loss; fatigue; mouth sores. Specific side effects depend on individual patient reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older with AML that has come back or didn’t respond to treatment.

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I am between 18 and 69 years old and have not received any treatment for AML.

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

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

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I do not have any severe illnesses that could interfere with the study.

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My leukemia is either acute promyelocytic (M3) or core-binding factor.

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I do not have active leukemia in my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achievement of composite complete remission

Incidence of adverse events

Secondary study objectives

Biomarker changes

Event-free survival

Overall survival

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, venetoclax)Experimental Treatment2 Interventions

INDUCTION: Participants receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 of cycle 1 and on days 1 and 3 of cycle 2. Participants also receive venetoclax PO QD on days 2-21. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Participants receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 and venetoclax PO QD on days 2-21. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liposome-encapsulated Daunorubicin-Cytarabine

2017

Completed Phase 2

~170

Venetoclax

2019

Completed Phase 3

~2240