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

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Newly Diagnosed FLT3 Mutated AML Drug: Crenolanib Drug: Midostaurin Drug: Cytarabine Drug: Duanorubicin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Midostaurin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Crenolanib
Crenolanib following salvage chemotherapy
 Drug: Crenolanib
Crenolanib will be administered orally
Other Name: Crenolanib besylate

Drug: Cytarabine
100 mg/m² IV continuous infusion over 24 hours

Drug: Duanorubicin
90 mg/m2 IV
Active Comparator: Midostaurin
Midostaurin following salvage chemotherapy
 Drug: Midostaurin
Midostaurin will be administered orally

Drug: Cytarabine
100 mg/m² IV continuous infusion over 24 hours

Drug: Duanorubicin
90 mg/m2 IV


Outcome Measures
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Primary Outcome Measures :
  1. Event-free survival (EFS) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 7 years ]
  2. Relapse free survival [ Time Frame: 5 years ]
  3. Composite complete remission rate [ Time Frame: 5 years ]
  4. Duration of response [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258931


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

Locations
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Sponsors and Collaborators
Arog Pharmaceuticals, Inc.
More Information
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Responsible Party: Arog Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03258931    
Other Study ID Numbers: ARO-021
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cytarabine
Midostaurin
Crenolanib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
 Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors