Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 75
Updated:4/5/2019
Start Date:September 2016
End Date:November 2020
Contact:(for Asia Sites Only) Daiichi Sankyo Contact for Clinical Trial Information
Email:dsclinicaltrial@daiichisankyo.co.jp
Phone:+81-3-6225-1111(M-F 9-5 JST)

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A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used
in medical research.

Adults might be able to join this study after bone marrow tests show they have a certain kind
of blood cancer (FLT3-ITD AML).

Participants will have an equal chance of receiving quizartinib or placebo along with their
chemotherapy.

This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of
this study is to compare the effect of quizartinib versus placebo (administered with standard
induction and consolidation chemotherapy, then administered as continuation therapy for up to
36 cycles) on event-free survival in subjects with FLT3-internal tandem duplication (ITD)
positive AML.

Inclusion Criteria:

1. Must be competent and able to comprehend, sign, and date an Ethics Committee (EC) or
Institutional Review Board approved Informed Consent Form (ICF) before performance of
any study-specific procedures or tests;

2. Is ≥18 years or the minimum legal adult age (whichever is greater) and ≤75 years (at
Screening);

3. Newly diagnosed, morphologically documented primary AML or AML secondary to
myelodysplastic syndrome or a myeloproliferative neoplasm, based on the World Health
Organization (WHO) 2008 classification (at Screening);

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (at the time the
subject signs their first informed consent form);

5. Presence of FLT3-ITD activating mutation in bone marrow (allelic ratio of ≥3%
FLT3-ITD/total FLT3);

6. Participant is receiving standard "7+3" induction chemotherapy regimen as specified in
the protocol;

7. Adequate renal function defined as:

a. Creatinine clearance >50 mL/min, as calculated with the modified Cockcroft Gault
equation

8. Adequate hepatic function defined as:

1. Total serum bilirubin (TBL) ≤1.5 × upper limit of normal (ULN);

2. Serum alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase
(ALT) ≤2.5 × ULN;

9. Serum electrolytes within normal limits: potassium, calcium (total, or corrected for
serum albumin in case of hypoalbuminemia) and magnesium. If outside of normal limits,
subject will be eligible when electrolytes are corrected;

10. If a woman of childbearing potential, must have a negative serum pregnancy test upon
entry into this study and must be willing to use highly effective birth control upon
enrollment, during the treatment period and for 6 months following the last dose of
investigational drug or cytarabine, whichever is later. A woman is considered of
childbearing potential following menarche and until becoming postmenopausal (no
menstrual period for a minimum of 12 months);

11. If male, must be surgically sterile or willing to use highly effective birth control
upon enrollment, during the treatment period, and for 6 months following the last dose
of investigational drug or cytarabine, whichever is later.

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia (APL), French-American-British
classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12),
or breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1
(BCR-ABL) positive leukemia (ie, chronic myelogenous leukemia in blast crisis);
subjects 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).

2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms;

3. Prior treatment for AML, except for the following allowances:

- Leukapheresis;

- Treatment for hyperleukocytosis with hydroxyurea;

- Cranial radiotherapy for central nervous system (CNS) leukostasis;

- Prophylactic intrathecal chemotherapy;

- Growth factor/cytokine support;

4. Prior treatment with quizartinib or other FLT3-ITD inhibitors;

5. 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;

6. History of known CNS leukemia, including cerebrospinal fluid positive for AML blasts;
lumbar puncture is recommended for subjects with symptoms of CNS leukemia to rule out
extramedullary CNS involvement;

7. 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;

8. Uncontrolled or significant cardiovascular disease, including any of the following:

- Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;

- Fridericia's Heart Rate Correction Formula (QTcF) interval >450 msec;

- 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 (eg, ventricular
tachycardia, ventricular fibrillation, or Torsade de Pointes);

- History of second (Mobitz II) or third degree heart block (subjects with
pacemakers are eligible if they have no history of fainting or clinically
relevant arrhythmias while using the pacemaker);

- 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;

- Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the
institutional lower limit of normal;

- Complete left bundle branch block;

9. Active acute or chronic systemic fungal, bacterial, or viral infection not well
controlled by antifungal, antibacterial or antiviral therapy;

10. Known active clinically relevant liver disease (eg, active hepatitis B, or active
hepatitis C);

11. Known history of human immunodeficiency virus (HIV). Subjects should be tested for HIV
prior to Randomization if required by local regulations or EC;

12. History of hypersensitivity to any excipients in the quizartinib/placebo tablets;

13. Females who are pregnant or breastfeeding;

14. Otherwise considered inappropriate for the study by the Investigator.
We found this trial at
20
sites
111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-3202
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 501-590-1946
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Phone: 215-220-9675
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-942-5083
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Phone: 773-834-0492
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Cleveland, Ohio 44106
Phone: 216-844-8123
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Phone: 216-445-4506
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Durham, North Carolina 27715
Phone: 919-681-4769
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1600 Southwest Archer Road
Gainesville, Florida 90095
Phone: 352-273-6841
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
Phone: 551-996-3925
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Hershey, Pennsylvania 17033
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8111 South Emerson Avenue
Indianapolis, Indiana 46237
Phone: 317-528-4481
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Lexington, Kentucky 40536
Phone: 859-257-3041
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Los Angeles, California 90095
Phone: 310-794-0137
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1 Medical Center Drive
Morgantown, West Virginia 26506
304-598-4800
Phone: 304-293-5619
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
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Oklahoma City, Oklahoma 73104
Phone: 405-271-2090
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40 Paraguay
Rosario, Santa Fe 2000
Phone: +54 3414205500
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Shreveport, Louisiana 71103
Phone: 318-813-1404
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Tucson, Arizona 85724
Phone: 800-562-4789
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Valhalla, New York 10595
Phone: 914-493-8375
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