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A Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia

NCT03324243 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-01-10

No results posted yet for this study

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 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.

Conditions

  • Relapsed/Refractory FLT3-mutated AML

Interventions

DRUG

Crenolanib

66.7 mg/m2 three times a day (TID)

DRUG

Fludarabine

30 mg/m2/day, intravenous infusions over 30 mins.

DRUG

Cytarabine

2000 mg/m2/day, intravenous infusions over 1-3 hours.

Sponsors & Collaborators

  • Arog Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03324243 on ClinicalTrials.gov