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Anti-tumor antibiotic
CPX-351 for Myeloid Cancer
Phase 2
Recruiting
Led By Raul C. Ribeiro, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years from study entry
Awards & highlights
Summary
This trial looks at how a new drug can help people with a type of cancer called secondary myeloid neoplasms.
Who is the study for?
This trial is for young people aged 1 to less than 22 with secondary myeloid neoplasms (SMNs). They must have certain organ functions within normal ranges, no severe prior treatment effects, and not be on conflicting medications. Those with specific genetic conditions or other types of leukemia are excluded.
What is being tested?
The study tests CPX-351 (VYXEOS), a drug under investigation for treating SMNs. Participants may also undergo allogeneic hematopoietic stem cell transplantation if needed. The trial aims to understand the effectiveness and safety of CPX-351 in this patient group.
What are the potential side effects?
Potential side effects include reactions related to the immune system's response, possible damage to organs from chemotherapy drugs like daunorubicin/cytarabine in CPX-351, and complications from stem cell transplantation such as graft vs. host disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years from study entry
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years from study entry
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete remission with incomplete peripheral blood recovery (CRi) rates after one or two courses of CPX-351
Composite complete remission (CR) rates after one or two courses of CPX-351
Safety and tolerability in patients under 22 years of age with SMN treated with one or two courses of CPX-351 before HSCT
Secondary study objectives
Biologic correlates of response in patients with SMN after one or two courses of CPX-351
Event-free survival (EFS) of patients who received one or two courses of CPX-351 followed by HSCT
Overall (OS) survival of patients who received one or two courses of CPX-351 followed by HSCT
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CPX-351Experimental Treatment3 Interventions
Participants will receive CPX-351 for remission induction, and then will proceed to allogeneic HSCT or other therapies as per institutional practice.
Intrathecal (IT) chemotherapy will be given on Day 1 of each cycle, for all participants, but may be delayed if clinically indicated. IT cytarabine, IT methotrexate, and IT methotrexate/hydrocortisone/cytarabine (MHA) according to age are all acceptable.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPX-351
2022
Completed Phase 3
~1090
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
442 Previous Clinical Trials
5,308,844 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
249 Previous Clinical Trials
34,910 Total Patients Enrolled
2 Trials studying Myeloid Neoplasm
61 Patients Enrolled for Myeloid Neoplasm
Raul C. Ribeiro, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
1 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with MDS/AML caused by previous cancer treatment.I have been diagnosed with AML for the first time.I am between 1 and 21 years old.I have received a high dose of a specific chemotherapy drug.My brain functions are mostly normal, with minor issues.I can take care of myself but may not be able to do heavy physical work.I am taking medication for a weak heart pump.I am sexually active and not using birth control.I haven't taken any immunosuppressive drugs in the last 2 weeks.I have a specific genetic disorder or type of leukemia.My kidney function is good, with a filtration rate over 70 mL/min.I am not pregnant or breastfeeding.My liver is working well, with bilirubin levels not too high.I have recovered from side effects of my previous cancer treatments.I do not have an active, uncontrolled infection.
Research Study Groups:
This trial has the following groups:- Group 1: CPX-351
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.
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