A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT04209725|
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : June 5, 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/or 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/or 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.
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|