Clinical Trials /

Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML

NCT03250338

Description:

This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
  • Official Title: Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: ARO-013
  • NCT ID: NCT03250338

Conditions

  • Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

Interventions

DrugSynonymsArms
CrenolanibCrenolanib besylateCrenolanib
CytarabineCrenolanib
MitoxantroneCrenolanib
Placebo Oral TabletPlacebo
FludarabineCrenolanib
IdarubicinCrenolanib
G-CSFCrenolanib

Purpose

This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.

Trial Arms

NameTypeDescriptionInterventions
CrenolanibExperimentalCrenolanib following salvage chemotherapy
  • Crenolanib
  • Cytarabine
  • Mitoxantrone
  • Fludarabine
  • Idarubicin
  • G-CSF
PlaceboPlacebo ComparatorPlacebo following salvage chemotherapy
  • Cytarabine
  • Mitoxantrone
  • Placebo Oral Tablet
  • Fludarabine
  • Idarubicin
  • G-CSF

Eligibility Criteria

        Inclusion Criteria:

          1. Confirmed diagnosis of AML according to World Health Organization (WHO) 2016
             classification

          2. Presence of FLT3-ITD and/or D835 mutation(s)

          3. Subjects must be primary refractory or relapsed to 1st line intensive treatment for
             AML or refractory or relapsed after second line of treatment for AML

          4. Age ≥ 18 years and ≤ 75 years

          5. Adequate hepatic function

          6. Adequate renal functions

          7. ECOG performance status ≤ 3

        Exclusion Criteria:

          1. Known clinically active central nervous system(CNS) leukemia

          2. Severe liver disease

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

          4. Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of
             quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior
             use of hydroxyurea or other palliative treatment for leukocytosis is allowed.

          5. Previous treatment with crenolanib or prior participation in clinical trial involving
             crenolanib.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Event-free survival (EFS)
Time Frame:3 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival
Time Frame:3 years
Safety Issue:
Description:
Measure:Relapse-free Survival (RFS)
Time Frame:3 years
Safety Issue:
Description:
Measure:Complete remission rate (CR)
Time Frame:3 years
Safety Issue:
Description:
Measure:MRD negative complete remission rate
Time Frame:3 years
Safety Issue:
Description:

Details

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

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