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Nucleoside Analog
CPX-351 vs CLAG-M for Acute Myeloid Leukemia
Phase 2
Recruiting
Led By Roland Walter
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of untreated "high-grade" myeloid neoplasm (>=10% blasts in blood or bone marrow) or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2016 World Health Organization (WHO) classification. Outside diagnostic material is acceptable to establish diagnosis; submission of peripheral blood specimen for flow cytometry performed at the study institution should be considered. Diagnostic material must have been submitted for cytogenetic and/or molecular testing as clinically appropriate
Treatment-related mortality (TRM) score >= 13.1 as calculated with simplified model
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
Study Summary
This trial is studying CPX-351 or the CLAG-M regimen to see how well they work in treating patients with acute myeloid leukemia or other high-grade myeloid neoplasms who are not physically fit enough for standard doses of CPX-351.
Who is the study for?
This trial is for less-fit patients with untreated high-grade myeloid neoplasms or AML, excluding acute promyelocytic leukemia. Participants must have a specific risk score (TRM >= 13.1), agree to use contraception, and be able to consent. Prior low-intensity treatments are allowed; significant liver function and heart health are required.Check my eligibility
What is being tested?
The study compares CPX-351 chemotherapy against the CLAG-M regimen in treating medically less-fit patients with certain types of blood cancer. It aims to determine if full doses used for fitter patients could be more effective than reduced doses in this population.See study design
What are the potential side effects?
Chemotherapy drugs like CPX-351 and those in the CLAG-M regimen can cause side effects such as nausea, fatigue, increased infection risk due to lowered white blood cell counts, hair loss, mouth sores, and potential damage to organs like the heart or liver.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a specific type of untreated high-grade blood cancer, not including APL.
Select...
My treatment risk score is 13.1 or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
3-month overall survival (OS)
Secondary outcome measures
30-day mortality rate
60-day mortality
Complete remission (CR) rates
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (CLAG-M)Experimental Treatment6 Interventions
INDUCTION: Patients receive cladribine IV over 2 hours on days 1-5, cytarabine IV over 2 hours on days 1-5, G-CSF SC on days 0-5, and mitoxantrone IV over 60 minutes on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients who achieve a response other than an MRDneg CR receive a second course of cladribine IV over 2 hours on days 1-5, cytarabine IV over 2 hours on days 1-5, G-CSF SC on days 0-5, and mitoxantrone IV over 60 minutes on days 1-3 in the absence of disease progression or unacceptable toxicity.
POST-REMISSION: Patients who achieve a CR/CRi receive an intermediate dose of cytarabine IV over 2 hours on days 1-6 for up to 4 additional courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (CPX-351)Experimental Treatment3 Interventions
INDUCTION: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients who achieve a response other than an MRDneg CR receive a second course of CPX-351 intravenously IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity.
POST-REMISSION: Patients who achieve a CR/CRi receive a reduced dose of CPX-351 IV over 90 minutes on days 1, 3, and 5 for up to 4 additional courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Mitoxantrone
2008
Completed Phase 3
~1510
Cladribine
2014
Completed Phase 4
~4390
Recombinant Granulocyte Colony-Stimulating Factor
2018
Completed Phase 2
~70
Liposome-encapsulated Daunorubicin-Cytarabine
2016
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,185 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,225 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,208 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bilirubin levels are below 2.0 mg/mL, or higher for specific medical reasons.I have a severe form of leukemia and cannot be treated with tyrosine kinase inhibitors.You have a known allergy or extreme sensitivity to any of the drugs being used in this study.I have an infection, but it is being treated or is under control.I have used hydroxyurea but will stop before the study starts. I may have had treatments for high WBC or tumor complications.I have a specific type of untreated high-grade blood cancer, not including APL.I am not on any leukemia treatments, except possibly a FLT3-inhibitor for FLT3-mutated AML.My treatment risk score is 13.1 or higher.I have received mild treatments for a previous low-grade blood disorder.My heart pumps well, with an ejection fraction of 45% or higher.I have a health condition that may reduce my life expectancy to less than a year.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (CPX-351)
- Group 2: Arm II (CLAG-M)
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.
Has the FDA validated Liposome-encapsulated Daunorubicin-Cytarabine for therapeutic use?
"Our research team assessed the safety of Liposome-encapsulated Daunorubicin-Cytarabine at a score of 2 as this clinical trial is in its Phase 2, which means that there are preliminary data affirming its security but no documented proof on effectiveness."
Answered by AI
How is Liposome-encapsulated Daunorubicin-Cytarabine typically employed to benefit patients?
"Liposome-encapsulated Daunorubicin-Cytarabine is a treatment of choice for ewing's tumor. It can also assist with newly diagnosed therapy-related acute myeloid leukemia, acute lymphoblastic leukemia (ALL), and chronic phase myeloid leukemia."
Answered by AI
Is enrollment open for this trial at present?
"Affirmative. The clinicaltrials.gov website displays that this medical trial is actively looking for volunteers; it was first advertised on March 11th 2020 and its most recent amendment was performed on September 7th 2022. Specifically, 60 individuals are needed from a single study site."
Answered by AI
Could you provide information regarding any previous experiments that utilized Liposome-encapsulated Daunorubicin-Cytarabine?
"Currently, 409 trials involving Liposome-encapsulated Daunorubicin-Cytarabine are underway. Of these, 96 have reached Phase 3 status. While the majority of research locations are located in New york City, there is a total of 15193 medical centres conducting trials for this medication."
Answered by AI
How many people are engaged in this medical experimentation?
"Indeed, according to clinicaltrials.gov information this trial is currently recruiting. It was initially posted on March 11th 2020 and has been updated as late as September 7th 2022. 60 individuals are required from a single site for study completion."
Answered by AI
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