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Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

NCT03258931

Description:

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
  • Official Title: Phase III Randomized Study of Crenolanib Versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects With FLT3 Mutated Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: ARO-021
  • NCT ID: NCT03258931

Conditions

  • Newly Diagnosed FLT3 Mutated AML

Interventions

DrugSynonymsArms
CrenolanibCrenolanib besylateCrenolanib
MidostaurinMidostaurin
CytarabineCrenolanib
DuanorubicinCrenolanib

Purpose

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.

Trial Arms

NameTypeDescriptionInterventions
CrenolanibExperimentalCrenolanib following salvage chemotherapy
  • Crenolanib
  • Cytarabine
  • Duanorubicin
MidostaurinActive ComparatorMidostaurin following salvage chemotherapy
  • Midostaurin
  • Cytarabine
  • Duanorubicin

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of de novo AML according to World Health Organization (WHO) 2016
             classification

          -  Presence of FLT3-ITD and/or D835 mutation(s) in bone marrow or peripheral blood

          -  Age ≥ 18 years and ≤ 60 years

          -  Adequate hepatic function within 48 hours prior to induction chemotherapy

          -  Adequate renal functions within 48 hours prior to induction chemotherapy

          -  ECOG performance status within 48 hours prior to induction chemotherapy ≤ 3

          -  Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified

        Exclusion Criteria:

          -  Acute promyelocytic leukemia (APL)

          -  Known clinically active central nervous system (CNS) leukemia

          -  Severe liver disease

          -  Active infections

          -  Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)

          -  Known infection with human immunodeficiency virus (HIV)

          -  Prior systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors,
             immunotherapy, or investigational agents)(except for hydroxyurea and/or leukapheresis)
      
Maximum Eligible Age:60 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Event-free survival (EFS)
Time Frame:5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival
Time Frame:7 years
Safety Issue:
Description:
Measure:Relapse free survival
Time Frame:5 years
Safety Issue:
Description:
Measure:Composite complete remission rate
Time Frame:5 years
Safety Issue:
Description:
Measure:Duration of response
Time Frame:5 years
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Arog Pharmaceuticals, Inc.

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