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Clinical Trials

Currently there are several clinical trials for acute myeloid leukemia (AML) 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.  Testing for these mutations is performed at LabPMM, talk to your physician about finding out your FLT3 status.

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: Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT01846624
Trial Phase II
Tyrosine Kinase Inhibitor, Manufacturer Midostaurin (PKC412), Novartis
Principal Investigator/s; Institution/s: Bruno C. Medeiros, National Cancer Institute
FLT3 Variation Required for Study Enrollment? Yes

Trial Name: Safety and Tolerability of AZD1208 and the Pharmacokinetics and Efficacy of AZD1208 in Acute Myelogenous Leukemia (AML) Patients
ClinicalTrials.gov Identifier: NCT01489722
Trial Phase I
Tyrosine Kinase Inhibitor, Manufacturer AZD1208, AstraZeneca
Principal Investigator/s; Institution/s: AstraZeneca
FLT3 Variation Required for Study Enrollment? No

Trial Name: Phase II Study of Crenolanib in Subjects With Relapsed AML With FLT3-D835 Activating Mutations
ClinicalTrials.gov Identifier: NCT01522469
Trial Phase II
Tyrosine Kinase Inhibitor, Manufacturer Crenolanib besylate, Arog Pharmaceuticals LLC
Principal Investigator/s; Institution/s: Arog Pharmaceuticals LLC
FLT3 Variation Required for Study Enrollment? Yes

Trial Name: Phase I/II Study of Combination of Sorafenib, Vorinostat, and Bortezomib for the Treatment of Acute Myeloid Leukemia With Complex- or Poor-risk (Monosomy 5/7) Cytogenetics or FLT3-ITD Positive Genotype
ClinicalTrials.gov Identifier: NCT01534260
Trial Phase I/II
Tyrosine Kinase Inhibitor, Manufacturer Sorafenib, Bayer
Principal Investigator/s; Institution/s: Hamid Sayar, MD, Indiana University Melvin and Bren Simon Cancer Center
FLT3 Variation Required for Study Enrollment? No

Trial Name: Protocol in Acute Myeloid Leukemia With FLT3-ITD
ClinicalTrials.gov Identifier: NCT01477606
Trial Phase II
Tyrosine Kinase Inhibitor, Manufacturer Midostaurin (PKC412), Novartis
Principal Investigator/s; Institution/s: Richard F Schlenk, MD, University Hospital of Ulm
FLT3 Variation Required for Study Enrollment? Yes

Trial Name: A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
ClinicalTrials.gov Identifier: NCT01657682
Trial Phase II
Tyrosine Kinase Inhibitor, Manufacturer Crenolanib besylate, Arog Pharmaceuticals LLC
Principal Investigator/s; Institution/s: Jorge Cortez, MD, MD Anderson
FLT3 Variation Required for Study Enrollment? Yes

Trial Name: Sorafenib Tosylate Before and After Donor Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT01578109
Trial Phase Open Label
Tyrosine Kinase Inhibitor, Manufacturer Sorafenib, Bayer
Principal Investigator/s; Institution/s: Keith W. Pratz, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
FLT3 Variation Required for Study Enrollment? Yes

Trial Name: Safety Study of AKN-028 in Patients With Acute Myelogenous Leukemia
ClinicalTrials.gov Identifier: NCT01573247
Trial Phase I/II
Tyrosine Kinase Inhibitor, Manufacturer AKN-028, Akinion Pharmaceuticals AB
Principal Investigator/s; Institution/s: Martin Hoeglund, MD, PhD, Uppsala University Hospital
FLT3 Variation Required for Study Enrollment? No

Trial Name: An Open Label Study to Evaluate the Safety and Efficacy of Two Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT01565668
Trial Phase II
Tyrosine Kinase Inhibitor, Manufacturer Quizartinib, Ambit
Principal Investigator/s; Institution/s: Medical Director, Astellas Pharma Global Development
FLT3 Variation Required for Study Enrollment? Yes

Trial Name: A Phase II Study of Crenolanib Besylate in Subjects With Relapsed Acute Myeloid Leukemia With FLT3-D835 Activating Mutations
ClinicalTrials.gov Identifier: NCT01522469
Trial Phase II
Tyrosine Kinase Inhibitor, Manufacturer Crenolanib Besylate (CP-868,596-26), Arog Pharmaceuticals LLC
Principal Investigator/s; Institution/s:

Margaret von Mehren, MD Fox Chase Cancer Center;

Michael C Heinrich, MD OHSU Knight Cancer Institute

FLT3 Variation Required for Study Enrollment? Yes

Trial Name:
Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT01253070
Trial Phase II
Tyrosine Kinase Inhibitor, Manufacturer Sorafenib (BAY 43-9006), Bayer
Principal Investigator/s; Institution/s: Geoffrey L. Uy, MD Washington University Siteman Cancer Center
FLT3 Variation Required for Study Enrollment? Yes

Trial Name: A Phase I Study of AC220 for Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
ClinicalTrials.gov Identifier: NCT01411267
Trial Phase I
Tyrosine Kinase Inhibitor, Manufacturer AC220, Ambit Biosciences
Principal Investigator/s; Institution/s: Therapeutic Advances in Childhood Leukemia Consortium
FLT3 Variation Required for Study Enrollment? No

Trial Name: Bortezomib and Sorafenib Tosylate in Patients With Newly Diagnosed Acute Myeloid Leukemia With or Without Mutations
ClinicalTrials.gov Identifier: NCT01371981
Trial Phase III
Tyrosine Kinase Inhibitor, Manufacturer Sorafenib, Bayer
Principal Investigator/s; Institution/s: Richard Aplenc, MD, MSCE, Children's Hospital of Philadelphia
FLT3 Variation Required for Study Enrollment? No

Trial Name: A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)
ClinicalTrials.gov Identifier: NCT01390337
Trial Phase I
Tyrosine Kinase Inhibitor, Manufacturer AC220, Ambit Biosciences Corp
Principal Investigator/s; Institution/s: Astellas Pharma Inc
FLT3 Variation Required for Study Enrollment? No

Trial Name:
Study Safety and Preliminary Efficacy of DCC-2036 in Patients With Leukemias (Ph+ CML and FLT3/ITD+ AML)
ClinicalTrials.gov Identifier: NCT00827138
Trial Phase I & II
Tyrosine Kinase Inhibitor, Manufacturer DCC-2036, Deciphera Pharmaceuticals LLC
Principal Investigator/s; Institution/s: Deciphera Pharmaceuticals LLC
FLT3 Variation Required for Study Enrollment? Yes

Trial Name:
Safety Study: Combination of Decitabine and Midostaurin in Patients Older Than 60 With Newly Diagnosed or Relapsed Refractory Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT01130662
Trial Phase I
Tyrosine Kinase Inhibitor, Manufacturer Midostaurin (PKC412), Novartis
Principal Investigator/s; Institution/s: Casey Williams, PharmD: University of Kansas Medical Center
FLT3 Variation Required for Study Enrollment? No

Trial Name:
Midostaurin and Azacitadine in Treating Elderly Patients With Acute Myelogenous Leukemia
ClinicalTrials.gov Identifier: NCT01093573
Trial Phase I & II
Tyrosine Kinase Inhibitor, Manufacturer Midostaurin (PKC412), Novartis
Principal Investigator/s; Institution/s: Brenda Cooper, MD: Ireland Cancer Center at University Hospitals, Case Medical Center, Case Comprehensive Cancer Center
FLT3 Variation Required for Study Enrollment? No

Trial Name:
Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML) (ACE)
ClinicalTrials.gov Identifier: NCT00989261
Trial Phase II
Tyrosine Kinase Inhibitor, Manufacturer AC220, Ambit Biosciences
Principal Investigator/s; Institution/s: Robert Corringham, MD; Ambit Biosciences Corporation
FLT3 Variation Required for Study Enrollment? Yes

Trial Name:
Granulocyte-colony Stimulating Factor (G-CSF) and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia (AML) With FLT3 Mutations
ClinicalTrials.gov Identifier: NCT00943943
Trial Phase I
Tyrosine Kinase Inhibitor, Manufacturer Sorafenib (BAY 43-9006), Bayer
Principal Investigator/s; Institution/s: Michael Andreeff, MD, PhD; M.D. Anderson Cancer Center
FLT3 Variation Required for Study Enrollment? Yes

Trial Name:
A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia
ClinicalTrials.gov Identifier: NCT00866281
Trial Phase I & II
Tyrosine Kinase Inhibitor, Manufacturer Midostaurin (PKC412), Novartis
Principal Investigator/s; Institution/s: Novartis Pharmaceuticals
FLT3 Variation Required for Study Enrollment? No

Trial Name:
Clinical Study of SU 11248 (Sutent) Combined With Standard Chemotherapy in Patients With FLT3 Mutated AML Over 60 Years
ClinicalTrials.gov Identifier: NCT00783653
Trial Phase I & II
Tyrosine Kinase Inhibitor, Manufacturer Sutent (Sunitinib/SU 11248), Pfizer
Principal Investigator/s; Institution/s: Walter Fiedler; Universitätsklinikum Hamburg-Eppendorf
FLT3 Variation Required for Study Enrollment? Yes