Vyxeos + Gemtuzumab Ozogamicin for Acute Myeloid Leukemia
Trial Summary
What is the purpose of this trial?
The purpose of the study is to determine the safety of combining the drugs gemtuzumab ozogamicin (GO) with CPX-351 in order to treat the disease, as well as to find the maximum tolerated dose level and recommended Phase 2 dose level of GO with a fixed dose of CPX-351.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does allow the use of hydroxyurea until the first day of study treatment. If you are on other medications, it's best to discuss with the study team to see if they are compatible with the trial.
What data supports the effectiveness of the drug Vyxeos + Gemtuzumab Ozogamicin for Acute Myeloid Leukemia?
Gemtuzumab ozogamicin, when combined with daunorubicin and cytarabine, showed improved event-free survival in patients with newly diagnosed acute myeloid leukemia (AML), while Vyxeos, a combination of daunorubicin and cytarabine in a liposomal form, demonstrated a significant improvement in overall survival compared to standard chemotherapy in high-risk AML patients.12345
Is Vyxeos + Gemtuzumab Ozogamicin safe for humans?
Vyxeos and Gemtuzumab Ozogamicin have been studied for safety in humans, showing some common side effects like prolonged low blood cell counts, infections, and liver issues. Serious side effects include bleeding and liver disease, but these treatments have been approved for use in certain types of leukemia, indicating a favorable balance between benefits and risks.45678
What makes the drug Vyxeos + Gemtuzumab Ozogamicin unique for treating acute myeloid leukemia?
This drug combination is unique because it targets the CD33 antigen on leukemia cells using Gemtuzumab Ozogamicin, a monoclonal antibody linked to a powerful toxin, and combines it with Vyxeos, a liposomal formulation of two chemotherapy drugs, daunorubicin and cytarabine, which work together to enhance the treatment's effectiveness.910111213
Research Team
Onyee Chan, MD
Principal Investigator
Moffitt Cancer Center
Eligibility Criteria
Adults aged 18-70 with newly diagnosed AML that's not high-risk, who can undergo intensive chemo and have CD33-expressing myeloblasts. They must be willing to use effective contraception, have no severe liver disease or heart failure, and cannot be pregnant or breastfeeding. Prior treatment for non-AML conditions is okay if it was over two weeks ago.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Dose escalation to determine the maximum tolerated dose (MTD) of CPX-351 in combination with Gemtuzumab Ozogamicin in participants with newly diagnosed acute myeloid leukemia.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Gemtuzumab Ozogamicin
- Vyxeos
Gemtuzumab Ozogamicin is already approved in United States, European Union for the following indications:
- Acute myeloid leukemia (AML)
- Acute myeloid leukemia (AML)
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Jazz Pharmaceuticals
Industry Sponsor
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland