Study of CPX-351 (VYXEOS) in Individuals Under 22 Years Old with Secondary Myeloid Neoplasms

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05656248

Provider View

This clinical trial is exploring the effects of a new drug, CPX-351, in young patients with secondary myeloid neoplasms (SMNs), a type of blood cancer.

Patient Parameters

Program Overview

The aim of this study is to understand how well the investigational drug CPX-351 works in treating young patients with secondary myeloid neoplasms (SMNs). Researchers want to see if the drug can help achieve remission, which means reducing or eliminating signs of cancer, and to evaluate its safety and side effects. Participants will receive up to two cycles of CPX-351 before potentially moving on to a stem cell transplant or other treatments, depending on their response to the drug.

Description

The main goal of this study is to see how effective CPX-351 is in achieving remission in young patients with secondary myeloid neoplasms (SMNs) and to assess its safety. Researchers will also look at the side effects and biological responses to the drug. They aim to estimate the survival rate over three years for patients who receive CPX-351 followed by a stem cell transplant.

Participants who qualify and agree to join the study will receive up to two cycles of CPX-351. If a patient achieves remission and has no detectable cancer cells after the first cycle, and a stem cell transplant can be arranged within 3 to 4 weeks, they may proceed to the transplant without needing a second cycle of CPX-351.

Eligibility Criteria

Inclusion Criteria

  • Must be between 1 and 22 years old.
  • Must have one of the following conditions:
    • Treatment-related myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) after previous cancer treatments.
    • Secondary MDS or AML, including certain genetic conditions or syndromes that increase the risk of these cancers.
  • Must be in good general health, able to perform daily activities with minimal assistance.
  • Must have good kidney, liver, and heart function as determined by specific medical tests.
  • Must have recovered from any previous cancer treatments.
  • Must not have received certain cancer treatments recently, with specific waiting periods required before starting CPX-351.
  • Patients with HIV can participate if their condition is well-controlled.
  • Patients with other solid tumors can participate if their treatment can be coordinated with this study.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Patients with newly diagnosed AML eligible for other specific trials.
  • Patients with certain genetic conditions or other specific types of leukemia.
  • Patients who have received high doses of certain chemotherapy drugs.
  • Patients currently taking another investigational drug.
  • Patients with heart conditions requiring specific medications.
  • Patients with active, uncontrolled infections.
  • Patients with active hepatitis B or C infections.
  • Patients with allergies to certain chemotherapy drugs.
  • Pregnant or breastfeeding females.
  • Females of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for six months after.

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