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Anti-tumor antibiotic, Anti-metabolites
CPX-351 + Quizartinib for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Led By Musa Yilmaz
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 =< 2
Diagnosis of AML (World Health Organization [WHO] classification definition of >= 20% blasts, excluding acute promyelocytic leukemia [APL]) or high risk MDS (> 10% bone marrow blasts)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment start till death or last follow-up id the patients is alive, assessed up to 5 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of CPX-351 in combination with quizartinib to treat acute myeloid leukemia and high risk myelodysplastic syndrome. CPX-351 contains chemotherapy drugs daunorubicin and cytarabine, which work in different ways to stop the growth of cancer cells. Quizartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The goal of this study is to learn if the combination of CPX-351 and quizartinib can help to control these diseases.
Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS), who have either not received chemotherapy or have had up to four prior treatments. Participants must be over 60 years old for the frontline cohort, and at least 18 for the relapsed/refractory cohort. They should have adequate organ function, no severe concurrent illnesses, and women of childbearing potential must use contraception.Check my eligibility
What is being tested?
The trial is testing CPX-351 (a combination of daunorubicin and cytarabine encapsulated in liposomes) alongside quizartinib to see if they can effectively control AML and MDS. It's a phase I/II study that aims to determine the best dose while monitoring side effects when these drugs are used together.See study design
What are the potential side effects?
Potential side effects include reactions related to organ inflammation due to immune response, infusion-related reactions from drug administration, fatigue, digestive issues like nausea or diarrhea, blood disorders such as anemia or clotting problems, increased risk of infections due to weakened immune defenses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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I have been diagnosed with AML or high-risk MDS, not including APL.
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I am 60 years old or older.
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I am 18 years or older and my cancer has returned or is not responding to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from treatment start till death or last follow-up id the patients is alive, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment start till death or last follow-up id the patients is alive, assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete remission (CRc) rate
Maximum tolerated dose
Secondary outcome measures
Duration of response (DOR)
Event-free survival
Overall survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CPX-351, quizartinib)Experimental Treatment2 Interventions
INDUCTION: Patients receive CPX-351 IV over 90 minutes on days 1, 3 and 5 and quizartinib PO on days 6-19. Patients who do not respond to treatment during cycle 1 receive CPX-351 IV on days 1 and 3 and quixartinib PO on days 6-19 during cycle 2. Treatment repeats every 28 days for up 2 cycles in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients receive CPX-351 over 90 minutes on days 1 and 3 and quizartinib PO on days 4-28 of cycle 1. Treatment with CPX-351 repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive quizartinib PO on days 1-28 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
2016
Completed Phase 2
~100
Quizartinib
2016
Completed Phase 3
~1110
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,081 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,269 Total Patients Enrolled
Musa YilmazPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
153 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I do not have major stomach or intestine problems that affect medication absorption.I have not had any major surgery in the last 14 days.I have been diagnosed with AML or high-risk MDS, not including APL.My heart function is impaired, with a QTc over 450 msec.I have a history of serious heart rhythm problems but have a pacemaker.I am not on medication that affects my heart's rhythm, except for essential infection treatments.I have congenital long QT syndrome.I am currently taking medication that strongly affects liver enzyme activity.I have a history of serious irregular heartbeats.I am not allergic to quizartinib, mannitol, CPX-351, or their ingredients.I have AML or MDS and have had 1-4 treatments for it.My family has a history of long QT syndrome.I have had a heart rhythm problem that needed treatment.I have not had chemotherapy for AML or MDS, but may have had other treatments.I have waited the required time after my last treatment to start the study therapy.I am a woman who can have children and have a recent negative pregnancy test, or I am a man who agrees to prevent pregnancy.I can take pills by mouth.I am 60 years old or older.I am 18 years or older and my cancer has returned or is not responding to treatment.I do not have severe health issues like uncontrolled diabetes or heart disease that could affect my participation.I haven't had a heart attack or unstable chest pain in the last 6 months.I have hepatitis B or C but my viral load is undetectable, or I've been vaccinated against hepatitis B.My heart condition is classified as severe or very severe.I am only in clinical trials for supportive care, not for other cancer treatments.I am using or will use effective birth control during and for 30 days after the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CPX-351, quizartinib)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are helping to progress this research?
"That is correct. The information available on clinicaltrials.gov verifies that this study, which was first announced on 5/27/2020, is still looking for subjects. In total, 52 individuals are needed across a single location."
Answered by AI
Are there any available positions for volunteers in this clinical research?
"Yes, this study is recruiting patients at present. It was originally posted on clinicaltrials.gov on May 27th, 2020 and has been edited most recently on September 30th, 2022."
Answered by AI
Could you please share how many times Liposome-encapsulated Daunorubicin-Cytarabine has been tested in the past?
"As of now, there are 280 ongoing clinical trials evaluating Liposome-encapsulated Daunorubicin-Cytarabine. Out of those, 68 are in Phase 3. New york City has the most active studies for this treatment (12538 total), though the majority of these are based in one city within the state."
Answered by AI
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