FLT3-ITD Mutation Clinical Trial
Official title:
Compassionate Use of Crenolanib for Cancers With Platelet Derived Growth Factor Receptor Alpha (PDGFRa) Mutations, PDGFRa Amplifications or Fms-like Tyrosine Kinase 3 (FLT3) Mutations
Compassionate use of crenolanib for patients with serious life-threatening illness that have
exhausted all available therapies used to treat the disease, with no other viable therapy
options, who is not eligible for clinical trials. This program is designed to evaluate the
requests on a patient by patient basis.
Patients must have documented evidence of a point mutation in position 842 in platelet
derived growth factor receptor alpha (PDGFRA-D842V) or amplification of PDGFRA or internal
tandem duplication within the FMS-like tyrosine kinase 3 (FLT3-ITD) or point mutations within
the tyrosine kinase domain (TKD) of FLT3 (FLT3-TKD)
This program is being offered on a patient by patient basis while phase 3 studies with
crenolanib are ongoing.
Institutional Review Board-/Independent Ethics Committee approval must be granted before, The
experimental intervention will be administered over 28-day cycles. Compassionate use of
crenolanib will be limited such that it does not interfere with the supply need for phase 3
studies.
There must be adequate understanding of the indication for the requested use.
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