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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achievement of composite complete remission
Incidence of adverse events
Secondary outcome measures
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
8%
Pericardial Effusion
8%
Infection
8%
Hypertension
4%
Cardiac Disorders
4%
Fever
4%
Intracranial Hemorrhage
4%
Pancreatitis
4%
Pleural Effusion
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)

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
Venetoclax
2019
Completed Phase 3
~1990
Liposome-encapsulated Daunorubicin-Cytarabine
2016
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,313 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,121 Total Patients Enrolled

Media Library

Liposome-encapsulated Daunorubicin-Cytarabine (Anti-tumor antibiotic, Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03629171 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Treatment (CPX-351, venetoclax)
Acute Myeloid Leukemia Clinical Trial 2023: Liposome-encapsulated Daunorubicin-Cytarabine Highlights & Side Effects. Trial Name: NCT03629171 — Phase 2
Liposome-encapsulated Daunorubicin-Cytarabine (Anti-tumor antibiotic, Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03629171 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what conditions has Liposome-encapsulated Daunorubicin-Cytarabine been found to be most efficacious?

"Liposome-encapsulated Daunorubicin-Cytarabine is usually prescribed for acute myelocytic leukemia. It may also be used to treat blast phase chronic myelocytic leukemia, lymphoma, and meningeal leukemia prophylaxis."

Answered by AI

Have any analogous studies been conducted regarding Liposome-encapsulated Daunorubicin-Cytarabine?

"Currently, there are 89 Phase 3 trials involving Liposome-encapsulated Daunorubicin-Cytarabine and 452 active studies in total. Toronto is the main hub of research related to this topic; however, it's being tested at 19158 sites worldwide."

Answered by AI

Are individuals able to enroll in this medical trial at the present moment?

"According to clinicaltrials.gov, this trial is recruiting patients as of now. It was initially posted on October 29th 2018 and its most recent edit was done July 8th 2022."

Answered by AI

How many participants can join this experiment?

"Affirmative. According to the information found on clinicaltrials.gov, this medical trial is actively recruiting patients; it was initially posted on October 29th 2018 and last modified on July 8th 2022. There are a total of 52 participants needed from a single site."

Answered by AI

Has the FDA granted authorization for Liposome-encapsulated Daunorubicin-Cytarabine?

"As this is a Phase-2 study, and although there are some safety data available, the efficacy of Liposome-encapsulated Daunorubicin-Cytarabine has yet to be clinically established. So it was assigned a score of 2."

Answered by AI
~18 spots leftby Dec 2026