20140106 (formerly CFZ008): Phase 1bStudy of Carfilzomib in Combination with Induction Chemotherapy in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia
Johns Hopkins Kimmel Cancer Center in Baltimore
This study is being done to find out if carfilzomib can be safely given before and during treatment with standard chemotherapy drugs in children and young adults with acute lymphoblastic leukemia (ALL).The use of carfilzomib in this study is investigational. The word "investigational" means carfilzomib is not approved by the U. S. Food and Drug Administration (FDA) to be used in combination with other standard chemotherapy drugs and is still being tested in research studies. However, the FDA is allowing the use of carfilzomib in this research study.Carfilzomib (Kyprolis) is a drug approved by the FDA (Food and Drug Administration) for the treatment of some adults with relapsed multiple myeloma, which is a type of blood cancer. It is not approved to treat ALL. It has not been given in combination with the other drugs used in this study.Carfilzomib is a type of drug called a proteasome inhibitor and works by preventing breakdown of proteins in cells, causing the cells to die. Cancer cells are more sensitive to these effects than normal cells.The goals of this study are:? To learn about the side effects (good and/or bad) of giving carfilzomib before and during chemotherapy using the standard drugs vincristine, dexamethasone, PEG-asparaginase and mitoxantrone.? To determine the best dose of carfilzomib that can be safely given to children and young adults in combination with standard chemotherapy to treat relapsed or refractory ALL.? To measure how effective the combination of carfilzomib with standard chemotherapy is at treating children and young adults with relapsed or refractory ALL.? To test the amount of carfilzomib in the blood after patients are given the drug.
Children with acute lymphoblastic leukemia (ALL) that has relapsed or been refractory to treatment may join. Relapse means the leukemia has come back after treatment. Refractory means that the leukemia did not go away during treatment.
Researchers will be doing this study in two parts. There will be a phase 1b part and phase 2 part of the study. In a phase 1b study, drugs are tested to evaluate the dosage that can be safely given. Drugs are given at different dosages until the highest dose without unacceptable side effects is found. In a Phase 2 study, the dose that is found to be safe in the Phase 1 study is used and its effectiveness against the cancer is evaluated. The study doctor will tell you which part you will be in.The study consists of 3 periods:? Screening Period: Various assessments and procedures will be done over about 1 week or less to determine if you are eligible to participate in the study.? Study Drug Period: You will receive 4 weeks of combination chemotherapy with carfilzomib (Induction). If you are in Phase 1b of the study, you will first receive 1 week of carfilzomib alone. If you tolerate carfilzomib and tests indicate that carfilzomib may be helping to control the ALL, you may be offered a second cycle of carfilzomib, this time in combination with a different groupof chemotherapy drugs (Consolidation). At any time during the study regimen, the study doctor may recommend to stop carfilzomib and proceed with another treatment.? End of Study Period: you will return to the clinic, or be contacted by telephone, about 30 days after the last dose of study drug, to assess your health status.
03/05/2019 05:03 AM