Study on CPX-351 or CLAG-M Treatment for Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Less-Fit Patients

Sponsor: Fred Hutchinson Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04195945

Provider View

This clinical trial is exploring how well two different treatment options, CPX-351 and the CLAG-M regimen, work for patients with acute myeloid leukemia or other high-grade myeloid neoplasms who are not in optimal health for standard treatments.

Patient Parameters

Program Overview

The purpose of this study is to see if CPX-351 or the CLAG-M regimen, which includes the drugs cladribine, cytarabine, G-CSF, and mitoxantrone, can effectively treat patients with acute myeloid leukemia or other high-grade myeloid neoplasms who are not as fit for standard treatments. These drugs work by stopping cancer cells from growing, dividing, or spreading. The study will compare the effectiveness of these treatments at doses typically used for healthier patients to see if they work better than reduced doses for less-fit patients.

Description

In this study, patients are randomly assigned to one of two treatment groups.

Group 1 (CPX-351 Treatment):

  • Induction Phase: Patients receive CPX-351 through an IV over 90 minutes on days 1, 3, and 5, unless the disease worsens or side effects are too severe. If the cancer responds but not completely, patients may receive a second round of CPX-351.
  • Post-Remission Phase: If patients achieve a complete response or a partial recovery, they receive a lower dose of CPX-351 for up to four more courses, unless the disease worsens or side effects are too severe.

Group 2 (CLAG-M Treatment):

  • Induction Phase: Patients receive cladribine and cytarabine through an IV over 2 hours on days 1-5, G-CSF as a shot on days 0-5, and mitoxantrone through an IV over 60 minutes on days 1-3, unless the disease worsens or side effects are too severe. If the cancer responds but not completely, patients may receive a second round of the same treatment.
  • Post-Remission Phase: If patients achieve a complete response or a partial recovery, they receive an intermediate dose of cytarabine for up to four more courses, unless the disease worsens or side effects are too severe.

After finishing the study treatment, patients will have follow-up visits periodically for up to five years to monitor their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with untreated high-grade myeloid neoplasm or acute myeloid leukemia (AML), excluding a specific type called acute promyelocytic leukemia.
  • A specific score indicating a higher risk of treatment-related mortality.
  • May have used hydroxyurea before joining the study, but it should be stopped before starting the study treatment.
  • May have received low-intensity treatment for a previous low-grade myeloid neoplasm.
  • Bilirubin levels below 2.0 mg/mL unless due to specific conditions like Gilbert's syndrome.
  • Heart function with an ejection fraction of 45% or higher.
  • Women of childbearing potential and men must agree to use effective birth control during the study and for at least four weeks after the last dose.
  • Must understand and agree to sign a consent form to participate.

Exclusion Criteria

  • Have a myeloid blast crisis of chronic myeloid leukemia unless not suitable for specific treatment.
  • Have another illness likely to result in survival of less than one year.
  • Have an active infection unless it is being treated and controlled.
  • Known allergy to any study drug.
  • Pregnant or breastfeeding.
  • Receiving any other anti-leukemia treatment, except for a specific FLT3-inhibitor for FLT3-mutated AML.

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