Trials / Withdrawn
WithdrawnNCT03324243
A Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia
A Phase II Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Arog Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 1 Year – 21 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2017-10-27
- Last updated
- 2019-01-10
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03324243. Inclusion in this directory is not an endorsement.