Study on Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for Treating Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04128748

Provider View

This clinical trial is testing a combination of two treatments, CPX-351 and quizartinib, to find the best dose and see if they can help control acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The study aims to understand the safety and effectiveness of this combination in patients with these conditions.

Patient Parameters

Program Overview

This study is exploring the use of a combination of two treatments, CPX-351 and quizartinib, for patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). CPX-351 is made up of two chemotherapy drugs, daunorubicin and cytarabine, which work to stop cancer cells from growing. Quizartinib may help by blocking certain enzymes needed for cancer cell growth. The study aims to find the safest and most effective dose of this combination and to see if it can help control these diseases.

Description

The study is divided into several phases:

Induction Phase: Patients will receive CPX-351 through an IV on days 1, 3, and 5, and quizartinib by mouth on days 6-19. If the cancer does not respond after the first cycle, patients may receive another cycle with CPX-351 on days 1 and 3 and quizartinib on days 6-19. Each cycle lasts 28 days, and patients can have up to 2 cycles if the disease does not progress or cause severe side effects.

Consolidation Phase: Patients will receive CPX-351 on days 1 and 3 and quizartinib on days 4-28 of the first cycle. CPX-351 treatment repeats every 28 days for 2 cycles if the disease does not progress or cause severe side effects.

Maintenance Phase: Patients will continue to take quizartinib by mouth on days 1-28 as long as the disease does not progress or cause severe side effects.

After completing the study treatment, patients will have follow-up visits at 30 days, then every 3-6 months for up to 5 years to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) with specific criteria.
  • For newly diagnosed patients: Must be 60 years or older and not have received prior chemotherapy for AML or MDS.
  • For relapsed or refractory patients: Must be 18 years or older and have received at least one prior treatment for AML or MDS.
  • Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
  • Must have certain blood and organ function levels within normal limits.
  • Must be able to take oral medication and understand the study requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
  • Men must agree to use a condom if their partner is of childbearing potential.

Exclusion Criteria

  • Known allergy to quizartinib, mannitol, CPX-351, or any of their components.
  • Significant electrolyte imbalances that cannot be corrected.
  • Severe gastrointestinal issues that affect the absorption of quizartinib.
  • Severe or uncontrolled medical conditions, including certain heart diseases or infections.
  • Known HIV or active hepatitis B or C infections, unless under control.
  • Recent consumption of grapefruit or Seville oranges.
  • Recent major surgery.
  • Certain heart conditions, including long QT syndrome or recent heart attack.
  • Use of medications that strongly affect liver enzymes or prolong the QT interval on an ECG.

Get This Program In Your Inbox

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