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

Phase 3

Recruiting

• Conditions: Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
• Interventions: Drug: Crenolanib; Drug: Cytarabine; Drug: Placebo Oral Tablet; Drug: Mitoxantrone; Drug: Fludarabine; Drug: Idarubicin; Drug: G-CSF

• Registration Number: NCT03250338
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-15
• Study Start: 2018-06-05
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-30
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 322

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Tablet	Placebo following salvage chemotherapy
Crenolanib	Crenolanib	Crenolanib following salvage chemotherapy
Crenolanib	Cytarabine	Crenolanib following salvage chemotherapy
Crenolanib	Mitoxantrone	Crenolanib following salvage chemotherapy
Crenolanib	G-CSF	Crenolanib following salvage chemotherapy
Crenolanib	Fludarabine	Crenolanib following salvage chemotherapy
Crenolanib	Idarubicin	Crenolanib following salvage chemotherapy
Placebo	Cytarabine	Placebo following salvage chemotherapy
Placebo	Mitoxantrone	Placebo following salvage chemotherapy
Placebo	Fludarabine	Placebo following salvage chemotherapy
Placebo	Idarubicin	Placebo following salvage chemotherapy
Placebo	G-CSF	Placebo following salvage chemotherapy

Primary Outcome Measures

Name	Time	Method
Event-free survival (EFS)	3 years

Secondary Outcome Measures

Name	Time	Method
MRD negative complete remission rate	3 years
Overall Survival	3 years
Relapse-free Survival (RFS)	3 years
Complete remission rate (CR)	3 years

Trial Locations

Locations (62)

City of Hope National Medical Center; 🇺🇸 Sacramento, California, United States

UC Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Kansas University; 🇺🇸 Kansas City, Kansas, United States

Karmanos Cancer Center; 🇺🇸 Detroit, Michigan, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Scroll for more (52 remaining)