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

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ClinicalTrials.gov Identifier: NCT03250338
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.

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

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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 2021
Estimated Study Completion Date : October 2021


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




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 ]


Information from the National Library of Medicine

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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.

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: Arun Prashar, MD 2144514523 aprashar@arogpharma.com

Locations
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United States, California
City of Hope National Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Chatchada Karanes, MD    626-218-2405    CKaranes@coh.org   
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Brian Jonas, MD    916-734-5959      
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Maxim Norkin, MD       maxim.norkin@medicine.ufl.edu   
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Hongtao Liu, MD       hliu@medicine.bsd.uchicago.edu   
United States, Kansas
Kansas University Recruiting
Kansas City, Kansas, United States, 666160
Contact: Sunil Abhyankar, MD         
Principal Investigator: Sunil Abhyankar, MD         
United States, Michigan
Karmanos Cancer Center Recruiting
Detroit, Michigan, United States, 48201
Contact: Jay Yang, MD       yangj@karmanos.org   
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Yue Guo, MD         
Principal Investigator: Yue Guo, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Eunice Wang, MD         
Principal Investigator: Eunice Wang, MD         
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: Rupali Bhave, MD    336-716-5487    rbhave@wakehealth.edu   
Italy
IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Recruiting
Meldola, Italy, 47014
Contact: Giovanni Mertinelli, MD    +39 0543739480    giovanni.martinelli@irst.emr.it   
Università del Piemonte Orientale Recruiting
Novara, Italy, 17
Contact: Monia Lunghi, MD    +39 0321 3732194    monia.lunghi@med.uniupo.it   
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

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Responsible Party: Arog Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03250338     History of Changes
Other Study ID Numbers: ARO-013
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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