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

• ClinicalTrials.gov Identifier: NCT03258931
• Recruitment Status: Recruiting
• First Posted: August 23, 2017
• Last Update Posted: May 22, 2020
• Sponsor: Arog Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Arog Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: August 21, 2017
• First Posted Date: August 23, 2017
• Last Update Posted Date: May 22, 2020
• Actual Study Start Date: August 15, 2018
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 21, 2017): Event-free survival (EFS) [ Time Frame: 5 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 21, 2017)

• Overall Survival [ Time Frame: 7 years ]
• Relapse free survival [ Time Frame: 5 years ]
• Composite complete remission rate [ Time Frame: 5 years ]
• Duration of response [ Time Frame: 5 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Newly Diagnosed FLT3 Mutated AML

Intervention

• Drug: Crenolanib
  Crenolanib will be administered orally
  Other Name: Crenolanib besylate
• Drug: Midostaurin
  Midostaurin will be administered orally
• Drug: Cytarabine
  100 mg/m² IV continuous infusion over 24 hours
• Drug: Duanorubicin
  90 mg/m2 IV

Study Arms

• Experimental: Crenolanib
  Crenolanib following salvage chemotherapy
  Interventions:

  • Drug: Crenolanib
  • Drug: Cytarabine
  • Drug: Duanorubicin
• Active Comparator: Midostaurin
  Midostaurin following salvage chemotherapy
  Interventions:

  • Drug: Midostaurin
  • Drug: Cytarabine
  • Drug: Duanorubicin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 21, 2017): 510
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2024
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: General Contact; 214-593-0500; info@arogpharma.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03258931
• Other Study ID Numbers: ARO-021
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Arog Pharmaceuticals, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Arog Pharmaceuticals, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Arog Pharmaceuticals, Inc.
• Verification Date: May 2020