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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 belowSelect...
I am 18 or older with AML that has come back or didn’t respond to treatment.
Select...
I am between 18 and 69 years old and have not received any treatment for AML.
Select...
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:Select...
I am not pregnant or breastfeeding.
Select...
I do not have any severe illnesses that could interfere with the study.
Select...
My leukemia is either acute promyelocytic (M3) or core-binding factor.
Select...
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
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 • NCT0228672625%
Febrile Neutropenia
21%
Neutropenic Fever
17%
Lung Infection
17%
Sepsis
13%
Insomnia
8%
Pericardial Effusion
8%
Infection
8%
Hypertension
4%
Pleural Effusion
4%
Pancreatitis
4%
Intracranial Hemorrhage
4%
Cardiac Disorders
4%
Fever
4%
Joint Effusion
4%
Alanine aminotransferase Increase
4%
Anxiety
4%
Blood Bilirubin Increase
4%
Acute Coronary Syndrome
4%
Respiratory Failure
4%
Multi-Organ Failure
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,274 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older with AML that has come back or didn’t respond to treatment, including prior venetoclax treatment.I am not pregnant or breastfeeding.I do not have any severe illnesses that could interfere with the study.My leukemia is either acute promyelocytic (M3) or core-binding factor.I am willing to use contraception during the study.I do not have active leukemia in my brain or spinal cord.I can take care of myself but might not be able to do heavy physical work.I am not pregnant and can prove it with a test taken in the last week.I understand the study's requirements and have signed the consent form.I am 18 or older with AML that has come back or didn’t respond to treatment.I am between 18 and 69 years old and have not received any treatment for AML.I've had treatments like hydroxyurea or ATRA without needing a break before joining this trial.I have previously been treated with CPX-351 or venetoclax for my relapsed or refractory disease.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CPX-351, venetoclax)
Awards:
This trial has 1 awards, including:- 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.