Viewing Study NCT03324243



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Last Modification Date: 2024-10-26 @ 12:34 PM
Study NCT ID: NCT03324243
Status: WITHDRAWN
Last Update Posted: 2019-01-10
First Post: 2017-10-18

Brief Title: A Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With RelapsedRefractory FLT3-Mutated Acute Myeloid Leukemia
Sponsor: Arog Pharmaceuticals Inc
Organization: Arog Pharmaceuticals Inc

Study Overview

Official Title: A Phase II Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With RelapsedRefractory FLT3-Mutated Acute Myeloid Leukemia
Status: WITHDRAWN
Status Verified Date: 2019-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Withdrawn Study halted prior to enrollment of first participant
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a phase II multicenter single-arm study to assess the safety and feasibility of combining crenolanib with fludarabine and cytarabine chemotherapy in pediatric patients with relapsedrefractory FLT3-mutated AML Patients will receive up to two courses of salvage chemotherapy with fludarabine cytarabine and crenolanib Response will be assessed between day 29-43 of each course
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None