Study on Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax for Treating Acute Myeloid Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03629171

Provider View

This clinical trial is testing a new combination of drugs, liposome-encapsulated daunorubicin-cytarabine and venetoclax, to see how well they work in treating acute myeloid leukemia (AML) that has returned, is resistant to treatment, or has not been treated yet.

Patient Parameters

Program Overview

This phase II study is exploring how effective a combination of liposome-encapsulated daunorubicin-cytarabine and venetoclax is in treating patients with acute myeloid leukemia (AML) that has come back, does not respond to treatment, or has not been treated. These chemotherapy drugs work by stopping cancer cells from growing, dividing, or spreading.

Description

The main goal of this study is to see how well the combination of liposome-encapsulated daunorubicin-cytarabine (CPX-351) and venetoclax works in achieving complete remission in patients with acute myeloid leukemia (AML). Researchers will also look at the safety of this treatment and how long patients live without the disease getting worse.

The study is divided into two parts: Induction and Consolidation.

During the Induction phase, participants will receive CPX-351 through an IV on specific days of the first two treatment cycles, and venetoclax will be taken orally daily for most of the cycle. Each cycle lasts 28 days, and this phase can last up to two cycles if the disease does not progress or cause unacceptable side effects.

In the Consolidation phase, participants will continue to receive CPX-351 and venetoclax in a similar manner, with treatment repeating every 28 days for up to four cycles, again depending on disease progression and side effects.

After completing the study treatment, participants will have follow-up visits at 30 days and then every three months for three years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with relapsed or refractory acute myeloid leukemia (AML) can participate in the initial phase.
  • Adults aged 18 to 69 with newly diagnosed AML who have not received prior treatment can join the second phase.
  • Previous use of certain emergency treatments is allowed.
  • Blood tests must show bilirubin levels of 2 mg/dL or less.
  • Liver enzymes (AST/ALT) must be within 3 times the normal limit, or 5 times if related to leukemia.
  • Kidney function must be within 1.5 times the normal limit.
  • Heart function must be 45% or higher.
  • General health status must be good, with a performance score of 2 or less.
  • Women of childbearing potential must have a negative pregnancy test before joining.
  • Participants must understand the study requirements and sign a consent form.

Exclusion Criteria

  • Pregnant or breastfeeding women cannot participate due to potential risks to the baby.
  • Individuals with uncontrolled illnesses, such as infections or severe heart conditions, are excluded.
  • Those allergic to any study drugs cannot participate.
  • Patients with specific types of leukemia, like acute promyelocytic leukemia, are excluded.
  • Individuals with active leukemia in the central nervous system cannot join.
  • Participants must agree to use contraception during the study.
  • Those who have previously received CPX-351 or venetoclax, except in certain cases, are excluded.

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