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Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients with FLT3-ITD Negative AML
EU CTIS ID: 2023-507936-20-00
What this study is testing
(Arm A vs. Arm B): The primary objective of the study is to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of OS in participants with newly diagnosed FLT3-ITD negative AML
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before performance of any trial-specific procedures or tests
- Male participants must not freeze or donate sperm starting at screening and throughout the trial period, and at least 4 months after the last dose of quizartinib/placebo, or for 6 months following the last dose of cytotoxic chemotherapy, whichever is later.
- Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions
- Consolidation Phase: Achieved CR or CRi, based on local laboratory results, at the end of the Induction Phase
- Consolidation Phase: Able to begin Consolidation Phase within 60 days of Day 1 of the last Induction cycle
- Maintenance Phase: Confirmed <5% of blasts based on the most recent bone marrow aspirate, based on the local laboratory results, performed within 28 days prior to Cycle 1 Day 1 of maintenance therapy
You likely can't join if
- Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis) (see details on pg 167)
- History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for at least 2 years.
- Uncontrolled or significant cardiovascular disease (for details see page 168)
- Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy. Note: Participants with localized fungal infections of skin or nails are eligible.
- Known active clinically relevant liver disease (eg, active hepatitis B or active hepatitis C), based on available blood tests, liver ultrasound, or liver biopsy results. Participants who are hepatitis B surface antigen positive (HBsAg+), with hepatitis B virus (HBV) infection for more than 6 months, have an HBV DNA viral load <2000 IU/mL, have normal transaminase values at baseline, and are willing to start and maintain antiviral treatment for the duration of the trial are allowed.
- Has active primary immunodeficiency or active human immunodeficiency virus ( HIV) infection as determined by plasma HIV RNA viral load and CD4 count. Participants with undetectable viral load or normalized CD4 count (CD4+ T-cell counts ≥350 cells/μL) and no opportunistic infection within the past 12 months will be eligible. These participants must be on established antiretroviral therapy for at least 4 weeks and have an HIV viral load <400 copies/mL prior to enrollment. Participants should be tested for HIV prior to randomization if required by local regulations or EC.
See the full eligibility criteria
Who can join
- Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before performance of any trial-specific procedures or tests
- Male participants must not freeze or donate sperm starting at screening and throughout the trial period, and at least 4 months after the last dose of quizartinib/placebo, or for 6 months following the last dose of cytotoxic chemotherapy, whichever is later.
- Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions
- Consolidation Phase: Achieved CR or CRi, based on local laboratory results, at the end of the Induction Phase
- Consolidation Phase: Able to begin Consolidation Phase within 60 days of Day 1 of the last Induction cycle
- Maintenance Phase: Confirmed <5% of blasts based on the most recent bone marrow aspirate, based on the local laboratory results, performed within 28 days prior to Cycle 1 Day 1 of maintenance therapy
- Maintenance Phase: Absolute neutrophil count (ANC) >500/mm3 and platelet count >50,000/mm3 without platelet transfusion support within 24 hours prior to Cycle 1 Day 1 of maintenance therapy
- Maintenance Phase: Able to begin Maintenance Phase within 60 days of Day 1 of the last Consolidation cycle received or within 180 days after allo-HSCT (ie, stable after transplant).
- Maintenance Phase: For participants who undergo allo-HSCT: Participant does not have active acute or ≥Grade 3 graft-versus-host disease (GVHD)or severe chronic GVHD.
- Maintenance Phase: For participants who undergo allo-HSCT: Participant has not initiated therapy for active GVHD (prophylaxis is allowed) within 21 days
- Maintenance Phase: For participants who undergo allo-HSCT: All Grade 3 and 4 non-hematological toxicities have resolved to ≤Grade 2 (with the exception of alopecia).
- ≥18 years or the minimum legal adult age (whichever is greater) and 70 years (at Screening)
- Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
- (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
- Participant is a candidate for standard “7+3” induction chemotherapy regimen as specified in the protocol per investigator assessment.
- Required baseline local laboratory data (see details on page 165)
- If a woman of childbearing potential, must have a negative serum pregnancy test upon entry into this trial and must be willing to use highly effective birth control upon enrollment, during the treatment period and for 7 months following the last dose of quizartinib/placebo or cytotoxic chemotherapy (i.e. anthracycline, cytarabine) whichever is later (see details on page 166)
- Female participants must not donate, or retrieve for their own use, ova from the time of initiation of 7+3 chemotherapy and throughout the trial treatment period and for at least 7 months after the final trial drug administration.
- If male, must be surgically sterile or willing to use highly effective birth control as well as a condom upon enrollment, during the treatment period, and for 4 months following the last dose of quizartinib/placebo, or for 6 months following the last dose of cytotoxic chemotherapy, whichever is later.
What rules you out
- Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis) (see details on pg 167)
- History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for at least 2 years.
- Uncontrolled or significant cardiovascular disease (for details see page 168)
- Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy. Note: Participants with localized fungal infections of skin or nails are eligible.
- Known active clinically relevant liver disease (eg, active hepatitis B or active hepatitis C), based on available blood tests, liver ultrasound, or liver biopsy results. Participants who are hepatitis B surface antigen positive (HBsAg+), with hepatitis B virus (HBV) infection for more than 6 months, have an HBV DNA viral load <2000 IU/mL, have normal transaminase values at baseline, and are willing to start and maintain antiviral treatment for the duration of the trial are allowed.
- Has active primary immunodeficiency or active human immunodeficiency virus ( HIV) infection as determined by plasma HIV RNA viral load and CD4 count. Participants with undetectable viral load or normalized CD4 count (CD4+ T-cell counts ≥350 cells/μL) and no opportunistic infection within the past 12 months will be eligible. These participants must be on established antiretroviral therapy for at least 4 weeks and have an HIV viral load <400 copies/mL prior to enrollment. Participants should be tested for HIV prior to randomization if required by local regulations or EC.
- Uncontrolled hypothyroidism
- History of severe hypersensitivity to any excipients in the quizartinib/placebo tablets
- Females who are pregnant or breastfeeding
- Otherwise considered inappropriate for the trial by the investigator including where other treatment options, such as gemtuzumab ozogamicin, are preferred according to local institutional practice.
- Treatment with any strong or moderate CYP3A inducers within 2 weeks or 5 half-lives of randomization whichever is longer.
- Diagnosis of AML secondary to prior chemotherapy or radiotherapy
- Diagnosis of AML with known antecedent myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and others.
- Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD [+]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.
- Prior treatment for AML, except for the following allowances prior to Day 1 of induction chemotherapy : a. Leukapheresis; b. Treatment for hyperleukocytosis with hydroxyurea; c. Cranial radiotherapy for central nervous system (CNS) leukostasis; d. Prophylactic intrathecal chemotherapy;
- Prior treatment with quizartinib or other FLT3 inhibitors (eg, midostaurin, sorafenib).
- Prior treatment with any investigational drug or device within 30 days prior to randomization (within 2 weeks for investigational or approved immunotherapy) or currently participating in other investigational procedures.
- Inadequate washout period before randomization, defined as major surgery <4 weeks or ≤2 weeks for low-invasive cases (eg, colostomy).
- Known CNS leukemia, including cerebrospinal fluid positive for AML blasts; lumbar puncture is recommended for participants with symptoms of CNS leukemia to rule out extramedullary CNS involvement
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Taiwan
- United States
- Korea, Republic of
- Singapore
- Serbia
- Australia
- Canada
- Hong Kong
- China
- Switzerland
- Japan
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Taiwan; United States; Korea, Republic of; Singapore; Serbia and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.