Phase 1b/2 Study of Carfilzomib in Combination with Induction Chemotherapy in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia
Sponsor: |
Amgen |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAO2351 |
U.S. Govt. ID: |
NCT02303821 |
Contact: |
Nobuko Hijiya: 212-305-9770 / nh2636@cumc.columbia.edu |
The purpose of this study is to learn more about the treatment of children and teenagers whose leukemia has come back (has relapsed) or has not gone away after other treatments (is refractory). Participants will receive the study drug, called carfilzomib in combination with standard chemotherapy, that are dexamethasone, daunorubicin, vincristine and PEG-asparaginase. The study consist of 3 periods: screening, treatment and end of study period. Participants with stable disease or better response at the end of the Induction Cycle will be offered an optional cycle of Consolidation chemotherapy.
This study is closed
Investigator
Nobuko Hijiya, MD
Does your child have a diagnosis of relapse or refractory acute lymphoblastic leukemia (ALL)? |
Yes |
No |
Are you between 1 and 21 years of age? |
Yes |
No |
Have you received prior therapy? |
Yes |
No |