Leukemia, Myeloid, AcutePhase 2NCT04209725
A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia
A Phase 2 study testing CPX-351 and Quizartinib in people with Leukemia, Myeloid, Acute, run by SCRI Development Innovations, LLC at 5 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- CPX-351 and Quizartinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Jun 2020to 20 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent form (ICF), according to local guidelines, signed by the patient or by a legal guardian prior to the performance of any study-related screening procedures.
- Patients with the following types of AML with >5% blasts:
- Relapsed FLT3-ITD mutation-positive AML, diagnosed by bone marrow (BM) biopsy with FLT3 mutation by polymerase chain reaction (PCR)
- Refractory FLT3-ITD mutation-positive AML, diagnosed by BM biopsy with FLT3 mutation by PCR
- Relapsed or refractory FLT3-ITD mutation-positive AML after HCT, diagnosed by BM biopsy with FLT3 mutation by PCR
- Relapsed or refractory AML with de novo FLT3-ITD mutation, diagnosed by BM biopsy with FLT3 mutation by PCR
Show all 11Show fewer
- Relapsed or refractory AML after HCT with de novo FLT3-ITD mutation, diagnosed by BM biopsy with FLT3 mutation by PCR
- First-line therapy must have contained a standard induction chemotherapy (e.g. 7+3, FLAG-IDA, FLAG, CLAG, MEC, hypomethylating agent with venetoclax) with or without receiving a prior FLT3 inhibitor (e.g. midostaurin) or multi-tyrosine kinase inhibitor (e.g. sorafenib). All patients who relapsed after an alloHCT are included, except patients with active graft-versus-host disease (GVHD) requiring >10 mg prednisone.
- Patients must be able to swallow and retain oral medication.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2 (Appendix A).
- Adequate renal and hepatic parameters (aspartate aminotransferase [AST], alanine aminotransferase [ALT] ≤2.5 institutional upper limit of normal [ULN]; total bilirubin ≤2.0 institutional ULN; serum creatinine [Cr] ≤2.0). In patients with suspected liver infiltration, ALT can be ≤5 institutional ULN.
Who cannot join
- Acute promyelocytic leukemia (t[15;17])
- Female patients who are lactating or have a positive serum pregnancy test during the screening period. Female patients of childbearing potential who are not willing to employ highly effective birth control (as defined in Appendix C of protocol) from screening to 6 months following the last dose of CPX-351 and/or quizartinib.
- Evidence of active and uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of active infection progression are present. This is assessed by the site clinicians, including an infectious disease consulting physician, if requested by the Principal Investigator (PI), regarding adequacy of therapy. These infections include, but are not limited to:
- Known human immunodeficiency virus (HIV) infection
- Active hepatitis B or C infection with rising transaminase values
- Active tuberculosis infection
Show all 24Show fewer
- History of hypersensitivity to cytarabine, daunorubicin, or an FLT3 inhibitor
- Any patients with known significant impairment in gastrointestinal (GI) function or GI disease that my significantly alter the absorption of quizartinib.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Uncontrolled or significant cardiovascular disease, including any of the following:
- Bradycardia of less than 50 beats per minute, unless the patient has a pacemaker
- QTcF interval using Fridericia's correction factor (QTcF) interval prolongation, defined as >450msec at screening and prior to first administration of quizartinib
- Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome)
- Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
- History of clinically relevant ventricular arrhythmias (i.e., ventricular tachycardia, ventricular fibrillation or Torsades de pointes)
- History of second or third degree heart block without a pacemaker
- Right bundle branch and left anterior hemiblock (bifascicular block), complete left bundle branch block
- Ejection fraction <50% by transthoracic echocardiogram (TTE) or multigated acquisition (MUGA) scan
- History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening
- History of New York Heart Association Class 3 or 4 heart failure
- Prior anthracycline (or equivalent) cumulative exposure ≥368 mg/m2 daunorubicin (or equivalent)
- Any serious underlying medical condition that, in the opinion of the Investigator or Medical Monitor, would impair the ability to receive or tolerate the planned treatment.
- Patients with inadequate adequate pulmonary function will be excluded. Inadequate pulmonary function is defined as requiring supplemental O2, or diffusing capacity of the lungs for carbon monoxide [DLCO] <40%.
- Active acute or chronic GVHD requiring prednisone >10 mg or equivalent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
St. David's South Austin Medical Center
Austin, Texas, 78704
Colorado Blood Cancer Institute
Denver, Colorado, 80218
HCA Midwest
Kansas City, Missouri, 64132
Tennessee Oncology
Nashville, Tennessee, 37203
Texas Transplant Institute
San Antonio, Texas, 78229
About this study
Official title: A Phase II Study Assessing CPX-351 (Vyxeos™) With Quizartinib for the Treatment of Relapsed or Refractory FLT3-ITD Mutation-Positive AML
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.
Read the detailed description
This is an open-label, two-part Phase II clinical trial in patients with relapsed or refractory FLT3-ITD mutation-positive acute myeloid leukemia (AML). The study is designed to assess the safety and tolerability as well as the efficacy of administering CPX-351 (cytarabine:daunorubicin liposome complex) with quizartinib. CPX-351 is a formulation of two drugs, cytarabine and daunorubicin, that is administered as the first part of treatment to get rid of as many leukemia cells in your bone marrow as possible. Quizartinib is an investigational drug made of a protein that inhibits FLT3 and will be given after CPX-351 has been given. The plan for administration is divided into three phases: induction, consolidation, and maintenance.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- CPX-351, Quizartinib
- Keywords
- FLT3
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPX-351Drug
Also called Vyxeos
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.
QuizartinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| CPX-351 and Quizartinib treatment | Experimental | Participants with FLT3 mutation positive AML will be given CPX-351 followed by quizartinib in three phases: induction, consolidation, and maintenance. Receives: Drug: CPX-351; Drug: Quizartinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Treatment Related Adverse Events After Taking CPX-351 and Quizartinib
Counting the number of patients with treatment related adverse events as a measure of safety and tolerability.
Measured: Collected during treatment and for 30 days after last dose, approximately 35 total days for the 1 patient treated.
Number of Patients With an Overall Response Taking CPX-351 and Quizartinib
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)
Measured: from cycle 1 day 1 (each cycle is 28 days) until disease progression for up to 2 years post treatment
Secondary outcomes (12)
Median Time to Platelet Count Recovery
Time to platelet recovery is defined as the time to when the peripheral blood platelet count is >50, 000/ μL
Measured: from cycle 1 Day 1 (each cycle is 28 days) for up to 24 months
Median Time to Absolute Neutrophil Count (ANC) Recovery
Time to neutrophil recovery is defined as the time to when the peripheral blood ANC is ≥500/μL
Measured: from Cycle 1 Day 1 (each cycle is 28 days) for up to 24 months
Number of Patients Proceeding to an Allogeneic Hematopoietic Cell Transplantation (alloHCT)
Patients receiving allogeneic hematopoietic cell transplantation (alloHCT) following treatment in induction and consolidation therapies.
Measured: up to 60 days after consolidation therapy
Median Time to Disease Progression
Time to disease progression, confirmed by bone marrow biopsy.
Measured: from diagnosis of relapse or refractory AML until disease progression for up to 2 years post treatment
Event-free Survival Time
Defined as the number of days until evidence of PD by bone marrow biopsy/aspirate, or death, regardless of cause. Patients who are alive without a disease response assessment of relapsed disease will be censored at the last adequate disease assessment date. Patients without a disease response assessment will be censored at the first date of treatment.
Measured: from day 1 for up to 4 years
Overall Survival (OS)
Overall survival is defined as the time from the first date of treatment until death as a result of any cause. For OS time, patients that have not died or are lost to follow-up will be censored at the date the patient was last known to be alive or the date of last contact.
Measured: Up to 8 months
Number of Patients Who Develop Late Responses
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
Measured: up to 4 years
Number of Patients Who Can Receive Consolidation and Maintenance Therapy
Patients who proceed through induction to next stages of consolidation and maintenance
Measured: approximately 3 months
Treatment-related Mortality Rate
As determined by the number of treatment related deaths during study treatment
Measured: Observed during treatment and for 30 days after last dose, so approximately 35 days for the 1 patient treated.
Percentage of Patients Who Achieve a PR or Molecular Complete Remission
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.
Measured: from cycle 1 day 1 (each cycle is 28 days) until disease progression for up to 2 years post treatment
Mean Elapsed Time for Patients to Achieve Molecular CR
The mean time to achievement of a complete morphologic CR with persistent disease detected by flow or molecular minimal residual disease (MRD) analysis.
Measured: From Date of First Treatment to up to 2 years
Quizartinib Tolerability After Allogeneic Hematopoietic Cell Transplantation (alloHCT) or Donor Lymphocyte Infusion (DLI)
Defined as the number of patients who received quizartinib and proceeded to alloHCT or DLI as part of this study and had treatment-related adverse events
Measured: From Date of First Treatment, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start3 Jun 2020
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Why it stopped: Closed due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Tees, MD, MPH, Study chair, Colorado Blood Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209725
- Sponsor's protocol ID
- SCRI AML 48
- Status last verified
- May 2022
- First submitted
- 20 Dec 2019
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Assessing CPX-351 (Vyxeos™) With Quizartinib for the Treatment of Relapsed or Refractory FLT3-ITD Mutation-Positive AML
- ClinicalTrials.gov ID
- NCT04209725
- Acronym / sponsor ID
- SCRI AML 48
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- FLT3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to slow enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Posted 3 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, two-part Phase II clinical trial in patients with relapsed or refractory FLT3-ITD mutation-positive acute myeloid leukemia (AML). The study is designed to assess the safety and tolerability as well as the efficacy of administering CPX-351 (cytarabine:daunorubicin liposome complex) with quizartinib. CPX-351 is a formulation of two drugs, cytarabine and daunorubicin, that is administered as the first part of treatment to get rid of as many leukemia cells in your bone marrow as possible. Quizartinib is an investigational drug made of a protein that inhibits FLT3 and will be given after CPX-351 has been given. The plan for administration is divided into three phases: induction, consolidation, and maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPX-351 and Quizartinib treatment | Experimental | Drug: CPX-351, Drug: QuizartinibParticipants with FLT3 mutation positive AML will be given CPX-351 followed by quizartinib in three phases: induction, consolidation, and maintenance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent form (ICF), according to local guidelines, signed by the patient or by a legal guardian prior to the performance of any study-related screening procedures.
- Patients with the following types of AML with >5% blasts:
- First-line therapy must have contained a standard induction chemotherapy (e.g. 7+3, FLAG-IDA, FLAG, CLAG, MEC, hypomethylating agent with venetoclax) with or without receiving a prior FLT3 inhibitor (e.g. midostaurin) or multi-tyrosine kinase inhibitor (e.g. sorafenib). All patients who relapsed after an alloHCT are included, except patients with active graft-versus-host disease (GVHD) requiring >10 mg prednisone.
- Patients must be able to swallow and retain oral medication.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2 (Appendix A).
Key exclusion criteria (24 listed)
- Acute promyelocytic leukemia (t[15;17])
- Female patients who are lactating or have a positive serum pregnancy test during the screening period. Female patients of childbearing potential who are not willing to employ highly effective birth control (as defined in Appendix C of protocol) from screening to 6 months following the last dose of CPX-351 and/or quizartinib.
- Evidence of active and uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of active infection progression are present. This is assessed by the site clinicians, including an infectious disease consulting physician, if requested by the Principal Investigator (PI), regarding adequacy of therapy. These infections include, but are not limited to:
- History of hypersensitivity to cytarabine, daunorubicin, or an FLT3 inhibitor
- Any patients with known significant impairment in gastrointestinal (GI) function or GI disease that my significantly alter the absorption of quizartinib.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPX-351Also: VyxeosGiven 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. | Drug | CPX-351 and Quizartinib treatment |
| QuizartinibGiven 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. | Drug | CPX-351 and Quizartinib treatment |
Primary outcome
Number of Patients With Treatment Related Adverse Events After Taking CPX-351 and Quizartinib
Time frame: Collected during treatment and for 30 days after last dose, approximately 35 total days for the 1 patient treated.
Counting the number of patients with treatment related adverse events as a measure of safety and tolerability.
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)
12 secondary outcomes
Median Time to Platelet Count Recovery
Time frame: from cycle 1 Day 1 (each cycle is 28 days) for up to 24 months
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
Number of Patients Proceeding to an Allogeneic Hematopoietic Cell Transplantation (alloHCT)
Time frame: up to 60 days after consolidation therapy
Median Time to Disease Progression
Time frame: from diagnosis of relapse or refractory AML until disease progression for up to 2 years post treatment
Event-free Survival Time
Time frame: from day 1 for up to 4 years
Overall Survival (OS)
Time frame: Up to 8 months
Number of Patients Who Develop Late Responses
Time frame: up to 4 years
Number of Patients Who Can Receive Consolidation and Maintenance Therapy
Time frame: approximately 3 months
Treatment-related Mortality Rate
Time frame: Observed during treatment and for 30 days after last dose, so approximately 35 days for the 1 patient treated.
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
Mean Elapsed Time for Patients to Achieve Molecular CR
Time frame: From Date of First Treatment to up to 2 years
Quizartinib Tolerability After Allogeneic Hematopoietic Cell Transplantation (alloHCT) or Donor Lymphocyte Infusion (DLI)
Time frame: From Date of First Treatment, up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Tees, MD, MPH study chair
Colorado Blood Cancer Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPX-351 and Quizartinib in people with Leukemia, Myeloid, Acute, run by SCRI Development Innovations, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Treatment Related Adverse Events After Taking CPX-351 and Quizartinib (time frame: Collected during treatment and for 30 days after last dose, approximately 35 total days for the 1 patient treated.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.