Clinical Trial: NCT02303821
Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Amgen |
| Information Provided By: | Amgen |
| Last Update Posted: | 2025-06-04 |
Study Overview
Brief 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.
Official Title
Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Conditions
Acute Lymphoblastic Leukemia (ALL)
Intervention / Treatment
- 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
Other Study ID Numbers
- CFZ008
- 2014-001633-84
- 2014
Start Date (Actual)
2015-02-16
Primary Completion Date (Actual)
2024-06-28
Study Completion Date (Actual)
2024-06-28
Enrollment (Actual)
141
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Amgen |
| Information Provided By: | Amgen |
| Last Update Posted: | 2025-06-04 |
Study Overview
Brief 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.
Official Title
Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Conditions
Acute Lymphoblastic Leukemia (ALL)
Intervention / Treatment
- 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
Other Study ID Numbers
- CFZ008
- 2014-001633-84
- 2014
Start Date (Actual)
2015-02-16
Primary Completion Date (Actual)
2024-06-28
Study Completion Date (Actual)
2024-06-28
Enrollment (Actual)
141
Study Type
Interventional
Phase
Phase 1