Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

PRIMARY OBJECTIVE: This is a pilot study to characterize the toxicity profile, to determine the maximum tolerated dose of the combination of crenolanib and sorafenib, and to determine the feasibility of administering these drugs in patients with relapsed or refractory hematologic malignancies, including acute myeloid leukemia (AML), AML with prior myelodysplastic syndrome (MDS), and myeloperoxidase (MPO)-positive mixed phenotype acute leukemia with FLT3-internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations. The study will include two phases: * The dose-escalation phase will characterize the dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of crenolanib when given in combination with sorafenib. * The dose-expansion cohort will further assess the safety and explore the efficacy of this combination.

Key facts

Study ID
NCT02270788
Run by
St. Jude Children's Research Hospital
People needed
10
Starts
2015-04-02
Expected to finish
2016-10-17
Last updated by the study team
2017-10-03

Who can join

Age: 1 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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