A Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03324243|
Recruitment Status : Withdrawn (Withdrawn: Study halted prior to enrollment of first participant)
First Posted : October 27, 2017
Last Update Posted : January 10, 2019
Arog Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.
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 relapsed/refractory 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.
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory FLT3-mutated AML||Drug: Crenolanib Drug: Fludarabine Drug: Cytarabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics: Core binding factor acute myeloid leukemia Cytogenetically normal acute myeloid leukemia Familial acute myeloid leukemia with mutated CEBPA
Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia
66.7 mg/m2 three times a day (TID)
Other Name: Crenolanib besylate
30 mg/m2/day, intravenous infusions over 30 mins.
2000 mg/m2/day, intravenous infusions over 1-3 hours.
Primary Outcome Measures :
- Number of patients experiencing ≥ Grade 3 adverse events as assessed by CTCAE v4.0 [ Time Frame: From study entry to 30 days post-treatment ]
- Number of patients experiencing Grade 4 adverse events related to crenolanib as assessed by CTCAE v4.0 [ Time Frame: 60 days ]
- Rate of early mortality [ Time Frame: 60 days ]Number of patients who died within 60 days of start of therapy
Secondary Outcome Measures :
- Event-free survival (EFS) [ Time Frame: 4 years ]EFS is defined as the time from the date of start of treatment to the date of failure to achieve a remission, relapse, or death from any cause.
- Relapse-free survival (RFS) [ Time Frame: 4 years ]RFS is defined as the time from the date of remission to date of relapse or death.
- Overall survival (OS) [ Time Frame: 4 years ]OS is defined as the time from the date of start of treatment until death.
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