Trials / Completed
CompletedNCT02303821
Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 1 Month – 21 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Carfilzomib | |
| DRUG | Dexamethasone | |
| DRUG | Mitoxantrone | |
| DRUG | PEG-asparaginase | |
| DRUG | Vincristine | |
| DRUG | Intrathecal (IT) Methotrexate | |
| DRUG | Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate) | |
| DRUG | 6-Mercaptopurine | |
| DRUG | Cyclophosphamide | |
| DRUG | Cytarabine | |
| DRUG | Daunorubicin |
Timeline
- Start date
- 2015-02-16
- Primary completion
- 2024-06-28
- Completion
- 2024-06-28
- First posted
- 2014-12-01
- Last updated
- 2025-06-04
- Results posted
- 2025-06-04
Locations
122 sites across 33 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, France, Greece, Hong Kong, Israel, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02303821. Inclusion in this directory is not an endorsement.