Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Completed · Phase 1
Conditions studied: Acute Lymphoblastic Leukemia (ALL)
In brief
The purpose of Phase 1b of this study is to: * Asses the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL). * Determine the maximum tolerated dose (MTD) and to recommend a phase 2 dose of carfilzomib in combination with induction chemotherapy. The purpose of Phase 2 of this study is to compare the rate of complete remission (CR) of carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin (VXLD) at the end of induction therapy to an appropriate external control.
Key facts
- Study ID
- NCT02303821
- Run by
- Amgen
- People needed
- 141
- Starts
- 2015-02-16
- Expected to finish
- 2024-06-28
- Last updated by the study team
- 2025-06-04
Who can join
Age: 0 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Childrens Hospital of Orange County — Orange, California, United States
- Childrens Hospital Colorado — Aurora, Colorado, United States
- Childrens Healthcare of Atlanta, Egleston — Atlanta, Georgia, United States
- Lurie Childrens Hospital of Chicago — Chicago, Illinois, United States
- The Sidney Kimmel Comprehensive Cancer Center at John Hopkins — Baltimore, Maryland, United States
- Childrens Hospital and Clinics of Minnesota — Minneapolis, Minnesota, United States
- Childrens Mercy Hospital — Kansas City, Missouri, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- Childrens Hospital of New York Presbyterian — New York, New York, United States
- Levine Childrens Hospital at Carolinas Medical Center d/b/a Atrium Health — Charlotte, North Carolina, United States
- Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Nationwide Childrens Hospital — Columbus, Ohio, United States
- Childrens Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Saint Judes Childrens Research Hospital — Memphis, Tennessee, United States
- Childrens Medical Center — Dallas, Texas, United States
- Texas Childrens Hospital West Tower — Houston, Texas, United States
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
- University of Utah Medical Center Primary Childrens Medical Center — Salt Lake City, Utah, United States
- West Virginia University Medicine Childrens — Morgantown, West Virginia, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Hospital Aleman — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Hospital Universitario Austral — Pilar, Buenos Aires, Argentina
- University of California San Francisco Benioff Childrens Hospital Oakland — Oakland, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.