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Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood

Primary Purpose

Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Quizartinib
Fludarabine
Cytarabine
Intrathecal (IT) triple chemotherapy prophylaxis
Etoposide
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute myeloid leukemia recurrent, Relapsed or refractory, FMS-like tyrosine kinase 3 positive, Cancer of the blood, AML, FLT3-ITD mutation

Eligibility Criteria

1 Month - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has diagnosis of AML according to the World Health Organization (WHO) 2008 classification with ≥5% blasts in bone marrow, with or without extramedullary disease
  • Is in first relapse or refractory to first-line high-dose chemotherapy with no more than 1 attempt (1 to 2 cycles of induction chemotherapy) at remission induction - prior HSCT is permitted
  • Has presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood as defined in the protocol
  • Is between 1 month and 21 years of age at the time the Informed Consent/Assent form is signed
  • Has protocol-defined adequate performance status score
  • Has fully recovered from the acute clinically significant toxicity effects of all prior chemotherapy, immunotherapy, or radiotherapy, per protocol guidelines
  • Has protocol-defined adequate renal, hepatic and cardiac functions
  • If of reproductive potential, is permanently sterile or agrees to use highly effective birth control upon enrollment, during the period of therapy, and for 6 months following the last dose of study drug or cytarabine, whichever is later
  • If female of child-bearing potential, tests negative for pregnancy and agrees not to breast feed
  • Participant/legal representative is capable of understanding the investigational nature of the study, potential risks, and benefits, and the patient (and/or legal representative) signs a written assent/informed consent
  • Meets protocol-specified guidelines before inclusion in the continuation therapy phase

Exclusion Criteria:

  • Has been diagnosed with isolated central nervous system relapse, certain kinds of leukemia, or with myeloid proliferations related to Down syndrome
  • Has uncontrolled or pre-defined significant cardiovascular disease as detailed in the protocol
  • Has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient must be off vasopressors and have negative blood cultures for at least 48 hours prior to the start of systematic protocol therapy.
  • Has known active clinically relevant liver disease (e.g., active hepatitis B or active hepatitis C)
  • Has known history of human immunodeficiency virus (HIV)
  • Has history of hypersensitivity to any of the study medications or their excipients
  • Is receiving or is anticipated to receive concomitant chemotherapy, radiation, or immunotherapy other than as specified in the protocol
  • Has any significant concurrent disease, illness, psychiatric disorder or social issue that would compromise subject safety or compliance, interfere with consent/assent, study participation, follow up, or interpretation of study results
  • Is currently participating in another investigative interventional procedure (observational or long-term interventional follow-up is allowed)
  • Is otherwise considered inappropriate for the study by the Investigator

Sites / Locations

  • Loma Linda University Cancer CenterRecruiting
  • University of California, San FranciscoRecruiting
  • Children's Hospital ColoradoRecruiting
  • A.I. duPont Hospital for ChildrenRecruiting
  • Children's National Medical CenterRecruiting
  • Children's Healthcare of AtlantaRecruiting
  • Riley Hospital for Children - Indiana UniversityRecruiting
  • Johns HopkinsRecruiting
  • University of Minnesota/Masonic Cancer CenterRecruiting
  • University of Mississippi Medical CenterRecruiting
  • Washington University School of Medicine
  • Columbia University/Herbert Irving Cancer CenterRecruiting
  • New York Medical College
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Children's Hospital of Philadelphia
  • UPMC Children's Hospital of PittsburghRecruiting
  • The University of Texas Southwestern Medical Center Children's HealthRecruiting
  • Seattle Children's HospitalRecruiting
  • Universitair Ziekenhuis GentRecruiting
  • The Hospital for Sick ChildrenRecruiting
  • Montreal Children's HospitalRecruiting
  • British Columbia Children's HospitalRecruiting
  • RigshospitaletRecruiting
  • Centre Léon BérardRecruiting
  • Hôpital Armand-TrousseauRecruiting
  • Hôpital des EnfantsRecruiting
  • Rambam Medical CenterRecruiting
  • Schneider Children's Medical Center of Israel
  • Tel Aviv Sourasky Medical CenterRecruiting
  • Fondazione IRCCS San Gerardo dei TintoriRecruiting
  • IRCCS Ospedale Pediatrico Bambino GesùRecruiting
  • Ospedale Infantile Regina MargheritaRecruiting
  • Prinses Maxima Centrum voor KinderoncologieRecruiting
  • Hospital Infantil Universitario Nino JesusRecruiting
  • Hospital Universitario La PazRecruiting
  • Sahlgrenska Universitetssjukhuset - Drottning Silvias Barn- och UngdomssjukhusRecruiting
  • NHS Greater Glasgow and Clyde - The Queen Elizabeth University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants

Arm Description

All participants will receive re-induction therapy that includes fludarabine and cytarabine in combination with experimental drug quizartinib. For prophylaxis, IT chemotherapy with cytarabine, methotrexate and prednisolone/hydrocortisone will be given prior to or between re-induction cycles. After completing re-induction therapy, eligible participants may also receive optional consolidation chemotherapy which includes cytarabine, etoposide and quizartinib, if HSCT is not available immediately. After completing re-induction or HSCT successfully, eligible participants can go on to receive continuation therapy with quizartinib.

Outcomes

Primary Outcome Measures

Number of dose-limiting toxicities (Phase 1)
Composite complete remission (CRc) rate among participants with acute myeloid leukemia (AML) (Phase 1 and 2)
CRc rate is defined as percentage of participants with best response of complete remission (CR) or CR with incomplete hematological recovery (CRi) after completion of up to 2 re-induction cycles
Pharmacokinetic parameter area under the concentration curve for quizartinib and AC886 (Phase 1 and 2)
Pharmacokinetic parameter apparent clearance (CL/F) for quizartinib and AC886 (Phase 1 and 2)
Pharmacokinetic parameter apparent volume of distribution (Vz/F) for quizartinib and AC886 (Phase 1 and 2)

Secondary Outcome Measures

Complete remission (CR) rate among participants with AML (Phase 1 and 2)
CR rate is defined as the percentage of participants achieving CR after completion of up to 2 re-induction cycles
Complete remission with incomplete recovery (CRi) rate among participants with AML (Phase 1 and 2)
CRi rate is defined as the percentage of participants achieving CRi after completion of up to 2 re-induction cycles
Duration of CR among participants with AML (Phase 1 and 2)
Duration of CR is defined as the time from the first documented CR until documented relapse
Duration of CRi among participants with AML (Phase 1 and 2)
Duration of CRi is defined as the time from the first documented CRi until documented relapse
Duration of composite complete remission (CRc) among participants with AML (Phase 1 and 2)
Duration of CRc is defined as the time from the first documented CR or CRi until documented relapse
Complete remission (CR) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)
CR rate after completion of re-induction Cycle 1 is defined as the percentage of participants achieving a CR after completion of re-induction Cycle 1
Complete remission with incomplete recovery (CRi) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)
CRi rate after completion of re-induction Cycle 1 is defined as the percentage of participants achieving a CRi after completion of re-induction Cycle 1
Composite complete remission (CRc) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)
CRc rate after completion of re-induction Cycle 1 is defined as the percentage of participants achieving CRc after completion of re-induction Cycle 1
Time to relapse among participants with AML (Phase 1 and 2)
Time to relapse is defined as the time from the first documented response (CR, CRi) until documented relapse
Rate of relapse among participants with AML after 1, 2 and 3 years (Phase 1 and 2)
Rate of relapse is defined as the percentage of participants who achieved CRc at the end of re-induction and had relapsed at 3 categorical time points Categories: 1 year, 2 years, 3 years
Cumulative incidence of relapse among participants with AML at the end of study (Phase 1 and 2)
Cumulative incidence of relapse at the end of the study is defined as the percentage of participants who achieved CRc at the end of re-induction and relapsed by the end of the study
Overall survival among participants with AML at 1, 2, and 3 years (Phase 1 and 2)
Overall survival is defined as the time from the start of re-induction therapy until death from any cause
Event-free survival among participants with AML at 1, 2, and 3 years (Phase 1 and 2)
Event-free survival is defined as the time from the start of re-induction therapy until the earliest date of the following: Refractory disease at the end of re-induction Relapse after CR or CRi Death from any cause at any time during the study
Number of participants proceeding to high-dose conditioning therapy/allogeneic hematopoietic stem cell transplantation (HSCT) (including transplant-related mortality) among participants with AML (Phase 1 and 2)
Rate of CRc (CR or CRi) without minimal residual disease (MRD) using next generation sequencing among participants with AML (Phase 1 and 2)
MRD is defined as the presence of leukemic cells in the bone marrow detected above a predefined cut-off level by a validated assay in participants who achieved a CR or CRi Categories: at screening, at re-induction cycle 1, at re-induction cycle 2, at time of relapse
Acceptability of including the palatability of quizartinib formulations among participants with AML (Phase 1 and 2)
Acceptability is assessed by palatability using a 5-point hedonic scale (from "Super bad" to "Super good") for participants who are developmentally able to answer. If unable, the caregiver provides information in a free text field stating whether the participant spit it out, may not have liked the flavor, etc.

Full Information

First Posted
January 2, 2019
Last Updated
October 11, 2023
Sponsor
Daiichi Sankyo, Inc.
Collaborators
Innovative Therapies For Children with Cancer Consortium, Children's Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT03793478
Brief Title
Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood
Official Title
A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) With FLT3-ITD Mutations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
May 1, 2027 (Anticipated)
Study Completion Date
May 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
Innovative Therapies For Children with Cancer Consortium, Children's Oncology Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to join this study if it has come back after remission or is not responding to treatment.
Detailed Description
The medical condition being investigated is relapsed or refractory AML in participants aged ≥1 month to ≤21 years with Feline McDonough Sarcoma (FMS)-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutations (FLT3-ITD AML), following failure of front-line intensive chemotherapy. The trial will be conducted in multiple phases. An independent data monitoring committee (DMC) will protect the rights, safety, and well-being of participants by monitoring the progress and results. The DMC will comprise qualified physicians and scientists who are not Investigators in the study and not otherwise directly associated with the Sponsor and will be convened at the end of Phase 1. A. Dose Escalation/De-escalation Phase: Number of participants is determined by age group. Participants will be enrolled by dose-level to determine the recommended Phase 2 dose (RP2D) of quizartinib for pediatric participants that provides similar exposure to adult patients treated at the target adult dose of 60 mg orally once daily. B. Dose-Expansion Phase: Participants will receive the RP2D of quizartinib for their respective age group. During both dose escalation and dose expansion phases, participants will receive: Re-Induction Therapy Intrathecal (IT) triple chemotherapy prophylaxis prior to and between cycles In re-induction Cycles 1 and 2, fludarabine/cytarabine (FLA) followed by quizartinib as a single agent Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Period: After re-induction therapy, participants will be evaluated for eligibility to undergo allogeneic hematopoietic stem cell transplant (HSCT). Eligible participants may receive a single 28-day cycle of consolidation therapy (standard of care chemotherapy with or without quizartinib) if an allogeneic HSCT is not available immediately. The options for consolidation therapy are as follows: High intensity chemotherapy with quizartinib, or Low intensity chemotherapy alone, or Low intensity therapy with quizartinib as a single agent Continuation Therapy: Participants in remission after HSCT, or who are not eligible for HSCT but achieve at least a partial remission (PR) after re-induction, will receive up to 12 continuous 28-day cycles of quizartinib continuation therapy at the same dose received during re-induction in the dose expansion phase. Long-term Follow-up: The long-term follow-up phase begins upon completion of 12 cycles of quizartinib Continuation Therapy or permanent discontinuation of quizartinib at any time. After completion of the 30-day safety follow-up visit, subsequent visits will occur at the following frequencies to assess survival and anti-leukemic treatments: every 3 months for the first 2 years, and then once a year thereafter until the last participant enrolled has been followed for three years from the date of enrollment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute myeloid leukemia recurrent, Relapsed or refractory, FMS-like tyrosine kinase 3 positive, Cancer of the blood, AML, FLT3-ITD mutation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
A single group will progress through a multiple phase study design as described in the detailed description.
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All Participants
Arm Type
Experimental
Arm Description
All participants will receive re-induction therapy that includes fludarabine and cytarabine in combination with experimental drug quizartinib. For prophylaxis, IT chemotherapy with cytarabine, methotrexate and prednisolone/hydrocortisone will be given prior to or between re-induction cycles. After completing re-induction therapy, eligible participants may also receive optional consolidation chemotherapy which includes cytarabine, etoposide and quizartinib, if HSCT is not available immediately. After completing re-induction or HSCT successfully, eligible participants can go on to receive continuation therapy with quizartinib.
Intervention Type
Drug
Intervention Name(s)
Quizartinib
Other Intervention Name(s)
Quizartinib dihydrochloride, Vanflyta
Intervention Description
Administered orally once daily starting on Day 6 and continuing through Day 28; Optional low intensity consolidation with chemotherapy: Administered orally once daily starting on Day 1 and continuing through Day 28
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
30 mg/m^2/day IV infusion given over 30 minutes on Days 1 through 5 (administered based on body weight)
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
2000 mg/m^2/day IV infusion given over 3 hours on Days 1 through 5 (begin 4 hours after the start of fludarabine) (administered in accordance with standard of care); Optional high intensity consolidation with chemotherapy and quizartinib: 500 mg/m^2/day as a continuous 96-hour IV infusion on Days 1 through 4; Optional low intensity consolidation with chemotherapy: 75 mg/m^2/day as once daily subcutaneous or IV on Days 1 through 4 and Days 15 through 18
Intervention Type
Drug
Intervention Name(s)
Intrathecal (IT) triple chemotherapy prophylaxis
Intervention Description
IT cytarabine, methotrexate, and either prednisolone or hydrocortisone; doses are based on the participant's age and standard practice at each site
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Optional high intensity consolidation with chemotherapy and quizartinib: 100 mg/m^2/dose once daily as an IV infusion over 3 hours on Days 1 through 5
Primary Outcome Measure Information:
Title
Number of dose-limiting toxicities (Phase 1)
Time Frame
Re-induction Cycle 1 Day 1 up to Day 28 (each cycle is 28 days)
Title
Composite complete remission (CRc) rate among participants with acute myeloid leukemia (AML) (Phase 1 and 2)
Description
CRc rate is defined as percentage of participants with best response of complete remission (CR) or CR with incomplete hematological recovery (CRi) after completion of up to 2 re-induction cycles
Time Frame
within 8 years, 8 months
Title
Pharmacokinetic parameter area under the concentration curve for quizartinib and AC886 (Phase 1 and 2)
Time Frame
Re-induction Phase 1 and 2,Cycle 1: Days 6, 20:Predose, 1 hour (Phase 1 only), 2, 4, and 6 hours; Days 7 and 21:24 hours; Phase 1 and 2 Cycle 2: Days 6 and 20:predose, 3 hours; Continuation Cycle 1 Days 1 and 15:predose, 2-4 hours (each cycle, 28 days)
Title
Pharmacokinetic parameter apparent clearance (CL/F) for quizartinib and AC886 (Phase 1 and 2)
Time Frame
Re-induction Phase 1 and 2,Cycle 1: Days 6, 20:Predose, 1 hour (Phase 1 only), 2, 4, and 6 hours; Days 7 and 21:24 hours; Phase 1 and 2 Cycle 2: Days 6 and 20:predose, 3 hours; Continuation Cycle 1 Days 1 and 15:predose, 2-4 hours (each cycle, 28 days)
Title
Pharmacokinetic parameter apparent volume of distribution (Vz/F) for quizartinib and AC886 (Phase 1 and 2)
Time Frame
Re-induction Phase 1 and 2,Cycle 1: Days 6, 20:Predose, 1 hour (Phase 1 only), 2, 4, and 6 hours; Days 7 and 21:24 hours; Phase 1 and 2 Cycle 2: Days 6 and 20:predose, 3 hours; Continuation Cycle 1 Days 1 and 15:predose, 2-4 hours (each cycle, 28 days)
Secondary Outcome Measure Information:
Title
Complete remission (CR) rate among participants with AML (Phase 1 and 2)
Description
CR rate is defined as the percentage of participants achieving CR after completion of up to 2 re-induction cycles
Time Frame
on Day 56 (± 3 Days) for the last subject, within 4 years
Title
Complete remission with incomplete recovery (CRi) rate among participants with AML (Phase 1 and 2)
Description
CRi rate is defined as the percentage of participants achieving CRi after completion of up to 2 re-induction cycles
Time Frame
on Day 56 (± 3 Days) for the last subject, within 4 years
Title
Duration of CR among participants with AML (Phase 1 and 2)
Description
Duration of CR is defined as the time from the first documented CR until documented relapse
Time Frame
within 8 years, 8 months
Title
Duration of CRi among participants with AML (Phase 1 and 2)
Description
Duration of CRi is defined as the time from the first documented CRi until documented relapse
Time Frame
within 8 years, 8 months
Title
Duration of composite complete remission (CRc) among participants with AML (Phase 1 and 2)
Description
Duration of CRc is defined as the time from the first documented CR or CRi until documented relapse
Time Frame
within 8 years, 8 months
Title
Complete remission (CR) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)
Description
CR rate after completion of re-induction Cycle 1 is defined as the percentage of participants achieving a CR after completion of re-induction Cycle 1
Time Frame
on Day 56 (± 3 Days) for the last subject, within 4 years
Title
Complete remission with incomplete recovery (CRi) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)
Description
CRi rate after completion of re-induction Cycle 1 is defined as the percentage of participants achieving a CRi after completion of re-induction Cycle 1
Time Frame
on Day 56 (± 3 Days) for the last subject, within 4 years
Title
Composite complete remission (CRc) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)
Description
CRc rate after completion of re-induction Cycle 1 is defined as the percentage of participants achieving CRc after completion of re-induction Cycle 1
Time Frame
on Day 56 (± 3 Days) for the last subject, within 4 years
Title
Time to relapse among participants with AML (Phase 1 and 2)
Description
Time to relapse is defined as the time from the first documented response (CR, CRi) until documented relapse
Time Frame
within 8 years, 8 months
Title
Rate of relapse among participants with AML after 1, 2 and 3 years (Phase 1 and 2)
Description
Rate of relapse is defined as the percentage of participants who achieved CRc at the end of re-induction and had relapsed at 3 categorical time points Categories: 1 year, 2 years, 3 years
Time Frame
within 8 years, 8 months
Title
Cumulative incidence of relapse among participants with AML at the end of study (Phase 1 and 2)
Description
Cumulative incidence of relapse at the end of the study is defined as the percentage of participants who achieved CRc at the end of re-induction and relapsed by the end of the study
Time Frame
within 8 years, 8 months
Title
Overall survival among participants with AML at 1, 2, and 3 years (Phase 1 and 2)
Description
Overall survival is defined as the time from the start of re-induction therapy until death from any cause
Time Frame
within 8 years, 8 months
Title
Event-free survival among participants with AML at 1, 2, and 3 years (Phase 1 and 2)
Description
Event-free survival is defined as the time from the start of re-induction therapy until the earliest date of the following: Refractory disease at the end of re-induction Relapse after CR or CRi Death from any cause at any time during the study
Time Frame
within 8 years, 8 months
Title
Number of participants proceeding to high-dose conditioning therapy/allogeneic hematopoietic stem cell transplantation (HSCT) (including transplant-related mortality) among participants with AML (Phase 1 and 2)
Time Frame
within 8 years, 8 months
Title
Rate of CRc (CR or CRi) without minimal residual disease (MRD) using next generation sequencing among participants with AML (Phase 1 and 2)
Description
MRD is defined as the presence of leukemic cells in the bone marrow detected above a predefined cut-off level by a validated assay in participants who achieved a CR or CRi Categories: at screening, at re-induction cycle 1, at re-induction cycle 2, at time of relapse
Time Frame
within 8 years, 8 months
Title
Acceptability of including the palatability of quizartinib formulations among participants with AML (Phase 1 and 2)
Description
Acceptability is assessed by palatability using a 5-point hedonic scale (from "Super bad" to "Super good") for participants who are developmentally able to answer. If unable, the caregiver provides information in a free text field stating whether the participant spit it out, may not have liked the flavor, etc.
Time Frame
within 8 years, 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for enrollment into the study: Has diagnosis of AML according to the World Health Organization (WHO) 2008 classification with ≥5% blasts in bone marrow, with or without extramedullary disease In first relapse or refractory to first-line high-dose chemotherapy with no more than 1 attempt (1 to 2 cycles of induction chemotherapy) at remission induction - prior HSCT is permitted Has presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood as defined in the protocol Is between 1 month and 21 years of age at the time the Informed Consent/Assent form is signed Has protocol-defined adequate performance status score Has fully recovered from the acute clinically significant toxicity effects of all prior chemotherapy, immunotherapy, or radiotherapy, per protocol guidelines Has protocol-defined adequate renal, hepatic and cardiac functions If of reproductive potential, is permanently sterile or agrees to use highly effective birth control upon enrollment, during the period of therapy, and for 6 months following the last dose of quizartinib, etoposide, fludarabine, methotrexate, or cytarabine, whichever is later If female of child-bearing potential, tests negative for pregnancy and agrees not to breast feed Male participants must be surgically sterile or willing to use highly effective birth control during the treatment period, and for 6 months following the last dose of quizartinib, etoposide, fludarabine, methotrexate, or cytarabine, whichever is later. Participant/legal representative is capable of understanding the investigational nature of the study, potential risks, and benefits, and the patient (and/or legal representative) signs a written assent/informed consent Exclusion Criteria: Participants who meet any of the following criteria will be disqualified from entering the study: Has been diagnosed with isolated central nervous system relapse, acute promyelocytic leukemia (APL), juvenile myelomonocytic leukemia, French-American-British classification M3 or WHO classification of APL with translocation, or with myeloid proliferations related to Down syndrome Has uncontrolled or pre-defined significant cardiovascular disease as detailed in the protocol Has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient must be off vasopressors and have negative blood cultures for at least 48 hours prior to the start of systematic protocol therapy. Has known active clinically relevant liver disease (e.g., active hepatitis B or active hepatitis C) Has known history of human immunodeficiency virus (HIV) Has history of hypersensitivity to any of the study medications or their excipients Is receiving or is anticipated to receive concomitant chemotherapy, radiation, or immunotherapy other than as specified in the protocol Has any significant concurrent disease, illness, psychiatric disorder or social issue that would compromise subject safety or compliance, interfere with consent/assent, study participation, follow up, or interpretation of study results Is currently participating in another investigative interventional procedure (observational or long-term interventional follow-up is allowed) Is otherwise considered inappropriate for the study by the Investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daiichi Sankyo Contact for Clinical Information
Phone
908-992-6400
Email
CTRinfo@dsi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
A.I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Riley Hospital for Children - Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Withdrawn
Facility Name
Columbia University/Herbert Irving Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Withdrawn
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
The University of Texas Southwestern Medical Center Children's Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Universitair Ziekenhuis Gent
City
Gent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Montreal Children's Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
British Columbia Children's Hospital
City
Vancouver
ZIP/Postal Code
V6H 3V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hôpital Armand-Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hôpital des Enfants
City
Toulouse
ZIP/Postal Code
31300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Schneider Children's Medical Center of Israel
City
Petah Tikva
ZIP/Postal Code
49202
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv-Yafo
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Fondazione IRCCS San Gerardo dei Tintori
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesù
City
Rome
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Ospedale Infantile Regina Margherita
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Prinses Maxima Centrum voor Kinderoncologie
City
Utrecht
ZIP/Postal Code
3584 EA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Infantil Universitario Nino Jesus
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Sahlgrenska Universitetssjukhuset - Drottning Silvias Barn- och Ungdomssjukhus
City
Göteborg
ZIP/Postal Code
41685
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
NHS Greater Glasgow and Clyde - The Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood

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