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Anti-tumor antibiotic
Liposome-encapsulated Daunorubicin-Cytarabine for Leukemia
Phase 1
Recruiting
Led By Guillermo M Bravo
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1.5 years
Awards & highlights
Study Summary
This trial is testing a new chemotherapy drug to see what the best dose is and what side effects it causes. The drug works by killing cancer cells or stopping them from growing.
Who is the study for?
This trial is for adults with high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia that's relapsed or resistant to treatment. They should not be candidates for a stem cell transplant, have certain levels of bone marrow blasts, and adequate kidney and liver function. Pregnant women, those with recent heart issues, uncontrolled infections, or who are on other treatments are excluded.Check my eligibility
What is being tested?
The study tests CPX-351 (liposome-encapsulated daunorubicin-cytarabine), aiming to find the best dose and assess side effects. It's designed for patients whose cancer has returned or didn't respond to prior therapies. The drug aims to stop cancer cells by killing them or preventing their growth and spread.See study design
What are the potential side effects?
Potential side effects include typical chemotherapy reactions such as nausea, fatigue, hair loss, increased risk of infection due to low blood counts, mouth sores, and potential damage to the heart muscle.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (dose-escalation stage)
Incidence of adverse events (dose-expansion stage)
Maximum-tolerated dose (MTD) of liposome-encapsulated daunorubicin-cytarabine (dose-escalation stage)
+1 moreSecondary outcome measures
Duration of response
Incidence of adverse events
Overall response rate
+2 moreSide effects data
From 2020 Phase 2 trial • 56 Patients • NCT0228672625%
Febrile Neutropenia
21%
Neutropenic Fever
17%
Lung Infection
17%
Sepsis
13%
Insomnia
8%
Infection
8%
Pericardial Effusion
8%
Hypertension
4%
Pancreatitis
4%
Intracranial Hemorrhage
4%
Cardiac Disorders
4%
Pleural Effusion
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)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (liposome-encapsulated daunorubicin-cytarabine)Experimental Treatment1 Intervention
INDUCTION THERAPY: 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. After 2-5 weeks, patients who do not achieve a CR/CRi/CRp, have acceptable or no toxicity, and have stable disease and no disease progression may receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients who achieve at least a HI response, receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After 5-8 weeks, patients who do not show clinically significant disease progression or unacceptable toxicity may receive liposome-encapsulated daunorubicin-cytarabine for up to 12 additional cycles.
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?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,279 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,483 Total Patients Enrolled
Guillermo M BravoPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
186 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a high dose of certain chemotherapy drugs, or less if I also had chest radiation.I am currently pregnant or breastfeeding.I have an infection that isn't getting better with antibiotics.My heart's pumping ability is significantly reduced.I am not currently on any experimental treatments or have had chemotherapy, radiotherapy, or immunotherapy in the last 14 days.I have had a heart attack in the last 6 months or have uncontrolled heart problems.I am a woman who can become pregnant and my pregnancy test was positive.My kidneys work well enough to clean my blood.I am taking medication to manage white blood cell count or using growth factors for my blood cells.My condition is high-risk MDS/CMML with significant bone marrow blasts.I have been diagnosed with MDS or CMML.I am willing to use effective birth control during the study.I am not going for a stem cell transplant now.My condition did not improve after 4+ treatments or got worse after initial improvement with specific drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (liposome-encapsulated daunorubicin-cytarabine)
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 is Liposome-encapsulated Daunorubicin-Cytarabine typically utilized?
"Liposome-encapsulated Daunorubicin-Cytarabine is a pharmaceutical typically prescribed for the treatment of leukemia, myelocytic, acute. However, it can also be beneficial in addressing blast phase chronic myelocytic leukemia and lymphoma as well as preventing meningeal leukaemia."
Answered by AI
How many individuals are partaking in this medical experiment?
"Affirmative. Clinicaltrials.gov data reveals that this trial, initially posted on May 14th 2019, is actively looking for participants to enrol. A total of 38 patients need to be sourced from one medical institution."
Answered by AI
What prior studies have been conducted with Liposome-encapsulated Daunorubicin-Cytarabine?
"At the current moment, 260 investigations concerning Liposome-encapsulated Daunorubicin-Cytarabine are active. Of those studies, 65 have progressed to Phase 3 and many of them originate in New york City with a total of 12359 trial sites hosting these trials worldwide."
Answered by AI
How hazardous is Liposome-encapsulated Daunorubicin-Cytarabine for individuals?
"The level of safety for Liposome-encapsulated Daunorubicin-Cytarabine was rated at 1, as this trial is in its earliest stage and scant data exists to support either efficacy or security."
Answered by AI
Is this research initiative still open to enrolment?
"According to information available on clinicaltrials.gov, this medical experiment is presently recruiting eligible individuals. Initially posted in May 2019 and updated most recently in June 2022, the trial seeks volunteers."
Answered by AI
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