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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years from study entry 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 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 outcome measures

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 more

Trial 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

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1200

CPX-351

2022

Completed Phase 3

~1090

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,588 Total Patients Enrolled

Jazz PharmaceuticalsIndustry Sponsor

248 Previous Clinical Trials

34,260 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

CPX-351 (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05656248 — Phase 2

Myeloid Neoplasm Research Study Groups: CPX-351

Myeloid Neoplasm Clinical Trial 2023: CPX-351 Highlights & Side Effects. Trial Name: NCT05656248 — Phase 2

CPX-351 (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05656248 — Phase 2

Frequently Asked Questions

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

Are the participants in this research exceeding 45 years of age?

"This research requires participants to be between 1 year and 21 years of age."

Answered by AI

Has CPX-351 been granted clearance by the US Food and Drug Administration?

"CPX-351's safety was appraised with a score of 2, as there is only anecdotal evidence concerning its efficacy and no prior studies have been done to prove it."

Answered by AI

Are there any open slots in this research trial at present?

"This trial, which was hosted on clinicaltrials.gov from 1/1/2023 to 12/9/2022 is no longer searching for candidates. However, there are currently 2414 other studies actively recruiting individuals."

Answered by AI

What are the core aims of this particular experiment?

"The primary aim of this investigation is to ascertain the Complete Remission with incomplete peripheral blood recovery (CRi) rates after one or two courses of CPX-351. Secondary objectives involve exploring biologic predictors for response via logistic regression modelling, assessing Event-free survival (EFS) utilising Kaplan Meier's method and calculating Overall Survival (OS). Measurements will take place no later than 42 days from each course commencement."

Answered by AI

Is it possible for me to sign up for this medical experiment?

"This medical trial is recruiting 25 patients between infancy and 21 with myeloid neoplasm. To qualify, they must fulfill the following conditions: be aged 1-22 years old at enrollment; have a history of being treated with alkylating agents, ionizing radiation, topoisomerase inhibitors etc.; possess an Eastern Cooperative Oncology Group score from 0 to 2; abide by concomitant medication restrictions as outlined in Section 4.2.5 or Appendix II of the protocol; have a creatinine clearance/radioisotope GFR over 70 mL/min/1.73m^2 (or serum"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms

2023. "Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05656248.

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