CPX-351 for Treating Secondary Acute Myeloid Leukemia in Patients Under 60

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04269213

Provider View

This study is testing how well a chemotherapy drug called CPX-351 works in treating younger patients with a specific type of leukemia called secondary acute myeloid leukemia. The drug aims to stop cancer cells from growing and spreading.

Patient Parameters

Program Overview

This phase II study is exploring the effectiveness of a chemotherapy drug called CPX-351 in treating patients under 60 years old with secondary acute myeloid leukemia (AML). CPX-351 is designed to stop cancer cells from growing by killing them or preventing them from dividing and spreading.

Description

The main goal of this study is to see how many patients achieve complete remission, meaning no signs of cancer, after treatment with CPX-351. Researchers will also look at how long patients stay in remission, their survival rates, and any side effects they experience.

Treatment Plan:

  • Induction Phase: Patients receive CPX-351 through an IV for 90 minutes on days 1, 3, and 5, unless the cancer worsens or side effects are too severe.
  • Re-Induction Phase: If the cancer does not go into remission, patients receive CPX-351 again on days 1 and 3.
  • Consolidation Phase: If patients achieve remission, they receive CPX-351 again 5-8 weeks after the last induction treatment, repeating every 45 days for up to 2 cycles.

After finishing the treatment, patients will have follow-up visits at 30 days, and then every 3 months for up to 5 years to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with specific types of acute myeloid leukemia (AML), such as therapy-related AML or AML with previous myelodysplastic syndrome (MDS).
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have normal kidney and liver function as indicated by specific blood tests.
  • Have a heart function of at least 50% as measured by specific tests.
  • Agree to use effective birth control methods during the study.
  • Women must have a negative pregnancy test before starting the study.
  • Willing to follow all study procedures and attend follow-up appointments.
  • Understand the study and agree to sign informed consent.

Exclusion Criteria

  • Have received prior treatment for AML.
  • Have active leukemia in the central nervous system.
  • Have certain types of leukemia, like core-binding factor leukemia or acute promyelocytic leukemia.
  • Have another uncontrolled cancer.
  • Have had high exposure to certain chemotherapy drugs in the past.
  • Have severe heart disease or recent heart attack.
  • Have allergies to the study drugs.
  • Have active HIV or hepatitis B or C infections.
  • Have severe liver disease.
  • Have an uncontrolled infection.
  • Are pregnant or breastfeeding.
  • Have severe medical or psychiatric conditions that could affect participation.
  • Have a history of Wilson disease or other copper-related disorders.
  • Any condition that makes the patient unsuitable for the study according to the investigator.

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