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Anti-tumor antibiotic

CPX-351 for Acute Myeloid Leukemia

Phase 2
Recruiting
Led By Steven Green, MD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Therapy-related acute myeloid leukemia (AML)
AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing how well CPX-351 works in treating patients with secondary acute myeloid leukemia who are younger than 60 years old.

Who is the study for?
This trial is for patients under 60 with secondary acute myeloid leukemia (AML) who haven't had AML treatment before. They must have good heart function, normal kidney and liver tests, and not be pregnant or breastfeeding. Participants need to use birth control and can't have severe diseases that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing CPX-351, a chemo drug combo of daunorubicin-cytarabine in liposomes, designed to kill cancer cells or stop them from growing and spreading. It's for younger patients to see how well it works against secondary AML.See study design
What are the potential side effects?
CPX-351 may cause side effects like heart problems due to daunorubicin; bone marrow suppression leading to low blood cell counts; infections; bleeding issues; nausea; vomiting; hair loss; liver toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have AML that developed after cancer treatment.
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My AML developed from a previous MDS or CMML condition.
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My leukemia is AML with changes related to MDS.
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I can take care of myself and am up and about more than half of my waking hours.
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I will use a latex condom during sex with women who can become pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response rate (morphological complete remission [CR] and incomplete blood count recovery [CRi])
Secondary outcome measures
Allogeneic hematopoietic cell transplant rate
CR + CRi duration
Event free survival
+2 more

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)Experimental Treatment1 Intervention
INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 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
2016
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
400 Previous Clinical Trials
30,787 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,347 Total Patients Enrolled
Steven Green, MDPrincipal InvestigatorRoswell Park Cancer Institute

Media Library

Liposome-encapsulated Daunorubicin-Cytarabine (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04269213 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Treatment (CPX-351)
Acute Myeloid Leukemia Clinical Trial 2023: Liposome-encapsulated Daunorubicin-Cytarabine Highlights & Side Effects. Trial Name: NCT04269213 — Phase 2
Liposome-encapsulated Daunorubicin-Cytarabine (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04269213 — Phase 2

Frequently Asked Questions

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

Are patients being sought for this clinical trial at this time?

"The clinical trial is still recruiting patients, as seen on clinicaltrials.gov. This research was initially posted on 7/29/2021 and updated for the last time on 5/5/2022."

Answered by AI

To be eligible for this research, what are the requirements?

"This leukemia study has room for 46 participants that are myeloid, between 18-59 years old."

Answered by AI

Does this research study have an age limit?

"This trial includes a patient population that is between 18-59 years old."

Answered by AI

Has the FDA given their okay to Liposome-encapsulated Daunorubicin-Cytarabine?

"While there is some evidence of Liposome-encapsulated Daunorubicin-Cytarabine's safety, as this is a Phase 2 trial, no efficacy data exists yet."

Answered by AI

What other similar medical experiments have been conducted with Liposome-encapsulated Daunorubicin-Cytarabine?

"There are a total of 276 clinical trials still active for Liposome-encapsulated Daunorubicin-Cytarabine, with 67 of those being in Phase 3. The majority taking place New york City, though there are 12,438 locations conducting these trials globally."

Answered by AI

What condition does Liposome-encapsulated Daunorubicin-Cytarabine target?

"Liposome-encapsulated Daunorubicin-Cytarabine is most commonly used to treat leukemia, myelocytic, and acute conditions. However, it can also be taken for multiple other conditions like blast phase chronic myelocytic leukemia, lymphoma, and prophylaxis of meningeal leukemia."

Answered by AI

How many people are willing to participate in this experiment?

"In order to successfully run this trial, 46 patients that meet the specific inclusion criteria are required. The sponsor, Jazz Pharmaceuticals, will be conducting the trial at different sites including Allegheny Health Network Cancer Institute - West Penn Hospital in Pittsburgh, Pennsylvania and University of Nebraska Medical Center in Omaha, Nebraska."

Answered by AI
~3 spots leftby Jan 2025