Trials Today

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

Purpose

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

Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Crenolanib	Crenolanib following salvage chemotherapy	Drug: Crenolanib Crenolanib will be administered orally Other names: 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

Recruiting Locations

More Details

NCT ID: NCT03250338
Status: Completed
Sponsor: Arog Pharmaceuticals, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.