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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03250338
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations Drug: Crenolanib Drug: Cytarabine Drug: Mitoxantrone Drug: Placebo Oral Tablet Drug: Fludarabine Drug: Idarubicin Drug: G-CSF Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 5, 2018
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


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

HAM regimen

FLAG-Ida


Drug: Mitoxantrone
HAM regimen

Drug: Fludarabine
FLAG-Ida regimen

Drug: Idarubicin
FLAG-Ida regimen

Drug: G-CSF
FLAG-Ida regimen
Placebo Comparator: Placebo
Placebo following salvage chemotherapy
 Drug: Cytarabine

HAM regimen

FLAG-Ida


Drug: Mitoxantrone
HAM regimen

Drug: Placebo Oral Tablet
Placebo will be administered orally

Drug: Fludarabine
FLAG-Ida regimen

Drug: Idarubicin
FLAG-Ida regimen

Drug: G-CSF
FLAG-Ida regimen


Outcome Measures
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Primary Outcome Measures :
  1. Event-free survival (EFS) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years ]
  2. Relapse-free Survival (RFS) [ Time Frame: 3 years ]
  3. Complete remission rate (CR) [ Time Frame: 3 years ]
  4. MRD negative complete remission rate [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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): NCT03250338


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.
Investigators
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Principal Investigator: Eunice Wang, MD Roswell Park Cancer Institute, Buffalo, New York, United States, 14263
More Information
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Responsible Party: Arog Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03250338    
Other Study ID Numbers: ARO-013
2017-001600-29 ( EudraCT Number )
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021

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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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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Fludarabine
Mitoxantrone
Idarubicin
Crenolanib
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic