Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).
Study details:
This is a clinical trial 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 overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 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.
- ≥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)
- Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
- Participant is receiving standard '7+3' induction chemotherapy regimen as specified in the protocol
Exclusion criteria
- 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); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
- Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms or autoimmune/rheumatologic conditions.
- Diagnosis of AML secondary to myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including CMML, aCML, 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: 1. Leukapheresis; 2. Treatment for hyperleukocytosis with hydroxyurea; 3. Cranial radiotherapy for central nervous system (CNS) leukostasis; 4. Prophylactic intrathecal chemotherapy; 5. Growth factor/cytokine support.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06578247
Intervention or treatment
DRUG: Quizartinib
DRUG: Placebo
DRUG: Chemotherapy
Conditions
- Leukemia
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Research sites nearby
Closest Location:
Royal Adelaide Hospital
Select from list below to view details:
Royal Adelaide Hospital
Adelaide, Australia
Flinders Medical Centre (Fmc)
Bedford Park, Australia
Box Hill Hospital
Box Hill, Australia
Concord Repatriation General Hospital
Concord, Australia
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Who is running the clinical trial?
Daiichi Sankyo
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Arm A: Quizartinib + Chemotherapy
| Drug: Quizartinib, Drug: Chemotherapy |
PLACEBO_COMPARATOR: Arm B: Placebo + Chemotherapy
| Drug: Placebo, Drug: Chemotherapy |
EXPERIMENTAL: Arm C: Quizartinib + Chemotherapy then Placebo Maintenance
| Drug: Quizartinib, Drug: Placebo, Drug: Chemotherapy |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (Arm A vs Arm B) | Overall survival (OS) is defined as the time from randomization until death from any cause. | Date of first patient randomized to the target number of deaths reached, up to approximately 42 months |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (Arm A vs. Arm B) | Event-free survival (EFS) is defined as failure to achieve Complete Remission (CR) (as assessed by Independent Review Committee (IRC)) at end of induction, relapse after CR, or death due to any cause, whichever occurs first | Date of randomization up to approximately 42 months |
| Duration of complete response (Arm A vs. Arm B) | Duration of complete response (DoCR) is defined as time from the first documented CR until documented relapse or death due to any cause, whichever comes first | Date of randomization up to approximately 42 months |
| Relapse-free survival (Arm A vs. Arm B) | Relapse-free survival (RFS) is defined as time from randomization, for participants who achieve CR in the Induction Phase, until relapse or death due to any cause, whichever comes first | Date of randomization up to approximately 42 months |
| Complete remission rate (Arm A vs. Arm B) | Complete remission rate (CR) is defined as proportion of of participants who achieved a CR | At end of Induction Phase, up to approximately 120 days |
| Complete remission rate with minimal or measurable residual disease (Arm A vs. Arm B) | Proportion of participants achieving CR with minimal or measurable residual disease (MRD) negativity | At end of Induction Phase (Cycle 1 or Cycles 1 and 2) and at the end of 2 cycles (2 cycles of induction or 1 cycle induction and 1 cycle consolidation)(1 Induction cycle is up to 60 days, 1 Consolidation cycle is 28 days), up to approximately 120 days |
| Number of Participants With Treatment-emergent Adverse Events (Arm A vs. Arm B) | Treatment-emergent adverse events (TEAE) are defined as those AEs with start or worsening date during the on-treatment period (from the first dose date of quizartinib/placebo to 30 days after the last dose date of quizartinib/placebo). | Date of first dose up to 30 days after last dose, up to approximately 42 months |
References
Clinical Trials Gov: Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AMLOther trials to consider
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