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Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

PHASE3NOT_YET_RECRUITING

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).

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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.

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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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-30

Primary completion: 2030-06-26

Study completion finish: 2030-06-26

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06578247

Intervention or treatment

DRUG: Quizartinib

DRUG: Placebo

DRUG: Chemotherapy

Conditions

• Leukemia

Condition: Leukemia
DRUG: Quizartinib and other drugs
Adelaide, Not Specified, Australia and more
Sponsor: Daiichi Sankyo

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, Not Specified, Australia
Flinders Medical Centre (Fmc)
Bedford Park, Not Specified, Australia
Concord Repatriation General Hospital
Concord, Not Specified, Australia
Liverpool Hospital
Liverpool, Not Specified, Australia

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 Participants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive quizartinib at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)	DRUG: Quizartinib Participants will receive quizartinib at 60 mg/day orally once daily
PLACEBO_COMPARATOR: Arm B: Placebo + Chemotherapy Participants will receive placebo at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)	DRUG: Placebo Participants will receive placebo at 60 mg/day orally once daily
EXPERIMENTAL: Arm C: Quizartinib + Chemotherapy then Placebo Maintenance Participants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)	DRUG: Quizartinib Participants will receive quizartinib at 60 mg/day orally once daily

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

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References

Clinical Trials Gov: Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML