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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

No Placebo-Only Group

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

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

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

CPX-351

2022

Completed Phase 3

~1170

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1240