Study on CPX-351 for Treating Older Patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS)

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT04668885

Provider View

This clinical trial is testing lower doses of the experimental drug CPX-351 in older patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who cannot undergo intensive chemotherapy. The study aims to see if CPX-351 can be effective for these patients after other treatments have failed.

Patient Parameters

Program Overview

The study is exploring the effectiveness of lower doses of CPX-351, an experimental drug, in older patients with relapsed or hard-to-treat acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) who are not eligible for intensive chemotherapy. CPX-351 combines two cancer-fighting drugs, cytarabine and daunorubicin, and is currently approved for certain types of AML. This trial is open-label, meaning both the researchers and participants know what treatment is being given. The study has two groups: one for patients with AML that has returned or not responded to treatment, and another for patients with high-risk MDS after other treatments have failed.

Description

Currently, older patients with AML and high-risk MDS who cannot receive intensive chemotherapy and have not responded to other treatments have limited options. CPX-351 is an experimental drug that combines two anti-cancer drugs, cytarabine and daunorubicin. It is approved for certain types of AML but is being tested here for other uses. This study is open-label, meaning both doctors and patients know what treatment is being given. The trial includes two groups: one for patients with AML that has returned or not responded to treatment, and another for patients with high-risk MDS after other treatments have failed.

Eligibility Criteria

Inclusion Criteria

  • Have AML that has returned or not responded to treatment and are not suitable for intensive chemotherapy.
    • AML is defined by specific medical criteria and includes those who did not achieve remission after certain chemotherapy cycles.
  • Have MDS that did not respond to or lost response to specific treatments.
  • Be in relatively good health with an ECOG performance status of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate liver and kidney function based on specific blood tests.
  • Be willing and able to understand and sign a consent form before starting the study.

Exclusion Criteria

  • Have active symptoms of cancer in the central nervous system.
  • Have had certain previous chemotherapy treatments for MDS or AML.
  • Have had more than two lines of previous non-intensive therapy.
  • Have severe heart disease or recent heart attack.
  • Have any serious medical condition or psychiatric illness that could increase risk or prevent understanding of the study.
  • Have another active cancer diagnosed within the past 6 months, except for certain skin or cervical cancers.
  • Have a history of allergic reactions to similar drugs.
  • Have uncontrolled illnesses, including infections or heart conditions.
  • Have a known history of HIV or active hepatitis B or C.
  • Have had major surgery within 2 weeks before joining the study.
  • Be pregnant or breastfeeding.
  • Be fertile and not agree to use effective birth control during and for 30 days after treatment.
  • Have acute promyelocytic leukemia (APL).

Locations

FACILITYZIPCITYSTATE
Cleveland Clinic, Case Comprehensive Cancer Center44106-5065ClevelandOhio

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.