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:	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:	Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML (CLAG ATRA AML)
ClinicalTrials.gov Identifier:	NCT01398501
Trial Phase	I
Tyrosine Kinase Inhibitor, Manufacturer	Midostaurin (PKC412), Novartis
Principal Investigator/s; Institution/s:	Camille Abboud, M.D.: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
FLT3 Variation Required for Study Enrollment?	No

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:	Sorafenib Maintenance Therapy for Patients With AML After Allogeneic Stem Cell Transplant
ClinicalTrials.gov Identifier:	NCT01161550
Trial Phase	I
Tyrosine Kinase Inhibitor, Manufacturer	Sorafenib, Bayer
Principal Investigator/s; Institution/s:	Yi-Bin A. Chen, MD, Massachusetts General Hospital
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

Trial Name:	Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Study of KW-2449 in Acute Myelogenous Leukemia (AML)
ClinicalTrials.gov Identifier:	NCT00779480
Trial Phase	I & II
Tyrosine Kinase Inhibitor, Manufacturer	KW-2449, Kyowa Pharmaceutical
Principal Investigator/s; Institution/s:	Terry F. Plasse; Kyowa Pharmaceutical
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 in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
ClinicalTrials.gov Identifier:	NCT00343694
Trial Phase	I
Tyrosine Kinase Inhibitor, Manufacturer	Sorafenib (BAY 43-9006), Bayer
Principal Investigator/s; Institution/s:	Brigitte C. Widemann, MD; NCI - Pediatric Oncology Branch
FLT3 Variation Required for Study Enrollment?	No

Trial Name:	Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias
ClinicalTrials.gov Identifier:	NCT00522990
Trial Phase	I & II
Tyrosine Kinase Inhibitor, Manufacturer	AT9283, Astex Therapeutics
Principal Investigator/s; Institution/s:	Hagop Kantarjian; M.D. Anderson Cancer Center
FLT3 Variation Required for Study Enrollment?	No

Trial Name:	RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS
ClinicalTrials.gov Identifier:	NCT00819546
Trial Phase	I
Tyrosine Kinase Inhibitor, Manufacturer	Midostaurin (PKC412), Novartis
Principal Investigator/s; Institution/s:	Richard Stone, MD; Dana-Farber Cancer Institute
FLT3 Variation Required for Study Enrollment?	No

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:	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