Currently there are several clinical trials for acute myeloid leukemia that include tyrosine kinase inhibitors (TKIs) that target FLT3. TKIs act to reduce the activity of FLT3 and other tyrosine kinase enzymes known to be important to the cancer process. Many of these trials require that the patient have a known FLT3 variation such as the Internal Tandem Duplication or the D835 variation.

Below are summaries of and links to the clinical trials which include TKIs targeting FLT3. The clinical trials listed are currently accepting new patients or soon will be.

Trial Name:
Lestaurtinib, Cytarabine, and Idarubicin in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT00469859
Trial Phase I & II
Tyrosine Kinase Inhibitor, Manufacturer Lestaurtinib (CEP-701), Cephalon
Principal Investigator/s; Institution/s: Patrick A. Brown, MD; Sidney Kimmel Comprehensive Cancer Center
Donald Small, MD, PhD; Sidney Kimmel Comprehensive Cancer Center
FLT3 Variation Required for Study Enrollment? Yes

Trial Name:
Study of CEP-701 in Patients With Acute Myeloid Leukemia (AML)
ClinicalTrials.gov Identifier: NCT00079482
Trial Phase II
Tyrosine Kinase Inhibitor, Manufacturer Lestaurtinib (CEP-701), Cephalon
Principal Investigator/s; Institution/s: Cephalon
FLT3 Variation Required for Study Enrollment? Yes

Trial Name:
Danorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT00651261
Trial Phase III
Tyrosine Kinase Inhibitor, Manufacturer Midostaurin (PKC412), Novartis
Principal Investigator/s; Institution/s: Richard M. Stone, MD; Dana-Farber Cancer Institute
FLT3 Variation Required for Study Enrollment? Yes

Trial Name:
Sorafenib and Cytarabine in Treating Older Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
ClinicalTrials.gov Identifier: NCT00516828
Trial Phase I & II
Tyrosine Kinase Inhibitor, Manufacturer Sorafenib (BAY 43-9006), Bayer
Principal Investigator/s; Institution/s: Brian Leber, MD, FRCPC, McMaster Children's Hospital
David A. MacDonald, MD, Nova Scotia Cancer Centre
FLT3 Variation Required for Study Enrollment? No

Trial Name:
Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)
ClinicalTrials.gov Identifier: NCT00542971
Trial Phase I & II
Tyrosine Kinase Inhibitor, Manufacturer Sorafenib (BAY 43-9006), Bayer
Principal Investigator/s; Institution/s: Farhad Ravandi Kashani, MD, M.D. Anderson Cancer Center
FLT3 Variation Required for Study Enrollment? No

Trial Name:
Sorafenib in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndromes, or Blastic Phase Chronic Myelogenous Leukemia
ClinicalTrials.gov Identifier: NCT00217646
Trial Phase I
Tyrosine Kinase Inhibitor, Manufacturer Sorafenib (BAY 43-9006), Bayer
Principal Investigator/s; Institution/s: Jorge Cortes, MD, M.D. Anderson Cancer Center
FLT3 Variation Required for Study Enrollment? No

Trial Name:
Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML
ClinicalTrials.gov Identifier: NCT00373373
Trial Phase II
Tyrosine Kinase Inhibitor, Manufacturer Sorafenib (BAY 43-9006), Bayer
Principal Investigator/s; Institution/s: Hubert Serve, MD; Klinikum der J.W. Goethe Universität Frankfurt
FLT3 Variation Required for Study Enrollment? No

Trial Name:
A Phase I Study of AC220 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Regardless of FLT3 Status
ClinicalTrials.gov Identifier: NCT00462761
Trial Phase I
Tyrosine Kinase Inhibitor, Manufacturer AC220, Ambit Biosciences
Principal Investigator/s; Institution/s: Ambit Clinical Research & Development
FLT3 Variation Required for Study Enrollment? No

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