drugset / Trial / NCT02779283

Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

NCT02779283

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase IB trial studies the feasibility of using a functional laboratory based study to determine how well the test can be used to select personalized kinase inhibitor therapy in combination with standard chemotherapy in treating patients with newly diagnosed acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). It also evaluates safety and potential efficacy. Kinase inhibitor is a type of substance that blocks an enzyme called a kinase. Human cells have many different kinase enzymes, and they help control important cell functions. Certain kinases are more active in some types of cancer cells and blocking them may help keep the cancer cells from growing. Testing samples of blood from patients with AML and ALL in the laboratory with kinase inhibitors may help determine which kinase inhibitor has more activity against cancer cells and which one should be combined with standard of care chemotherapy. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving a personalized kinase inhibitor therapy combined with standard chemotherapy may be a better treatment for AML and ALL.

Timeline

Start
2016-01-13
Primary completion
2018-04-19
Completion
2018-09-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Idelalisib Small molecule Oral
Subject Ponatinib Small molecule Oral
Subject Ruxolitinib Small molecule Oral
Subject Sorafenib Small molecule Oral
Subject Sunitinib Small molecule Oral
Subject dasatinib anhydrous Small molecule Oral
Background Cyclophosphamide Other / unclassified Intravenous
Background Cytarabine Small molecule Intravenous
Background Dexamethasone Small molecule Oral
Background Doxorubicin Other / unclassified Intravenous
Background Idarubicin Small molecule Intravenous
Background Leucovorin Small molecule Intravenous
Background Methotrexate Small molecule Intravenous
Background Methylprednisolone Other / unclassified Intravenous
Background Rituximab Monoclonal antibody Intravenous
Background Vincristine Small molecule Intravenous