A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04209725|
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : October 8, 2020
This is a research study to be done at multiple sites in participants with advanced acute myeloid leukemia (AML) that have a mutation in Fms-like tyrosine kinase-3 internal tandem duplications (FLT3-ITD). This study is to learn more about an investigational drug, quizartinib, being tested with the anti-cancer medicine CPX-351 (also called Vyxeos™), which is approved and widely used to treat AML.
The purpose of this study is to assess the safety, tolerability and survival of patients receiving the combination of CPX-351 and quizartinib.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute||Drug: CPX-351 Drug: Quizartinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Assessing CPX-351 (Vyxeos™) With Quizartinib for the Treatment of Relapsed or Refractory FLT3-ITD Mutation-Positive AML|
|Actual Study Start Date :||June 3, 2020|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2024|
Experimental: CPX-351 and Quizartinib treatment
Participants with FLT3 mutation positive AML will be given CPX-351 followed by quizartinib in three phases: induction, consolidation, and maintenance.
To be given during the induction and consildation phase and will consist of 44 mg/m^2 daunorubicin with 100 mg/m^2 cytarabine administered intravenously on Days 1, 3, and 5 during induction phase and Days 1 and 3 of consolidation phase.
Other Name: Vyxeos
To be given during induction, consolidation, and maintenance phases and will be taken orally at a dose of 30mg on Days 8-21 of induction phase, Days 6-21 of consolidation phase, and daily in maintenance phase.
- Number of patients with treatment related adverse events after taking CPX-351 and quizartinib [ Time Frame: from the start of treatment for approximately 24 months ]Counting the incidence of patients with treatment related adverse events as a measure of safety and tolerability.
- Determine the number of patients with an overall response taking CPX-351 and quizartinib [ Time Frame: from cycle 1 day 1 (each cycle is 28 days) until disease progression for up to 2 years post treatment ]Overall response is defined by the International Working Group response criteria (Cheson et al 2003) as having a complete remission (CR) - a complete morphologic response with complete blood count recovery absolute neutrophil count ≥1000/μL and platelet count ≥100,000/μL) or a complete morphologic response with an incomplete blood count recovery (CRi) - absolute neutrophil count <1000/μL and/or platelet count <100,000/μL)
- Median time to platelet count recovery [ Time Frame: from cycle 1 Day 1 (each cycle is 28 days) for up to 24 months ]Time to platelet recovery is defined as the time to when the peripheral blood platelet count is >50, 000/ μL
- Median time to absolute neutrophil count (ANC) recovery [ Time Frame: from Cycle 1 Day 1 (each cycle is 28 days) for up to 24 months ]Time to neutrophil recovery is defined as the time to when the peripheral blood ANC is ≥500/μL
- Number of patients proceeding to an allogeneic hematopoietic cell transplantation (alloHCT) [ Time Frame: up to 60 days after consolidation therapy ]Patients receiving allogeneic hematopoietic cell transplantation (alloHCT) following treatment in induction and consolidation therapies.
- Median time to disease progression [ Time Frame: from cycle 1 day 1 (each cycle is 28 days) until disease progression for up to 2 years post treatment ]Time to disease progression, confirmed by bone marrow biopsy.
- Determine event-free survival time [ Time Frame: from day 1 for up to 4 years ]Defined as the number of days until date of evidence of progressive disease by bone marrow biopsy/aspirate or death.
- Determine the number of patients who develop late responses [ Time Frame: up to 4 years ]Late responses as defined by the International Working Group response criteria (Cheson et al 2003) as having a complete remission (CR) - a complete morphologic response with complete blood count recovery absolute neutrophil count ≥1000/μL and platelet count ≥100,000/μL) or a complete morphologic response with an incomplete blood count recovery (CRi) - absolute neutrophil count <1000/μL and/or platelet count <100,000/μL
- Define the number of patients who can receive consolidation and maintenance therapy [ Time Frame: approximately 3 months ]Patients who proceed through induction to next stages of consolidation and maintenance
- Define the treatment-related mortality rate [ Time Frame: after end of treatment every 6 months for up to 2 years ]As determined by the number of treatment related deaths on study
- Determine the percentage of patients who achieve a PR or molecular complete remission [ Time Frame: from cycle 1 day 1 (each cycle is 28 days) until disease progression for up to 2 years post treatment ]A PR is defined as persistent disease by morphology but with a >50% reduction in the blast count/cellularity ratio compared to the most recent BM biopsy prior to treatment. A molecular complete remission is defined as no evidence of disease by bone marrow biopsy/aspirate by morphology, immunohistochemistry, or flow cytometry, and FLT3 mutation by MRD analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209725
|Contact: Sarah Cannon||844-710-6157||CANN.InnovationsMedical@sarahcannon.com|
|United States, Colorado|
|Colorado Blood Cancer Institute||Recruiting|
|Denver, Colorado, United States, 80218|
|Principal Investigator: Marcello Rotta, MD|
|United States, Missouri|
|Kansas City, Missouri, United States, 64132|
|Principal Investigator: Suman Kambhampati, MD|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator: William Donnellan, MD|
|United States, Texas|
|St. David's South Austin Medical Center||Recruiting|
|Austin, Texas, United States, 78704|
|Principal Investigator: Aravind Ramakrishnan, MD|
|Texas Transplant Institute||Recruiting|
|San Antonio, Texas, United States, 78229|
|Principal Investigator: Cesar Freytes, MD|
|Study Chair:||Michael Tees, MD, MPH||Colorado Blood Cancer Institute|