drugset / Trial / NCT02303821
Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Phase 1
Completed
141 enrolled
Amgen
Innovative Therapies For Children with Cancer Consortium · collabTherapeutic Advances in Childhood Leukemia & Lymphoma (TACL) - Study Design & Execution Collaborator · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-02-16
- Primary completion
- 2024-06-28
- Completion
- 2024-06-28
Publications
- Locatelli F, Karakukcu M, Huynh V, Gonzalez-Martinez B, Mendes Lins M, Lu MY, Sulis ML, Pauly M, Morris CL, Braunlin M, Talpes M, Gore L. Carfilzomib plus induction chemotherapy in children with relapsed or refractory acute lymphoblastic leukemia. Blood Adv. 2026 Jun 3:bloodadvances.2025019356. doi: 10.1182/bloodadvances.2025019356. Online ahead of print.
- Burke MJ, Ziegler DS, Bautista F, Attarbaschi A, Gore L, Locatelli F, M O'Brien M, Pauly M, Kormany WN, Tian S, Morris CL, Baruchel A. Phase 1b study of carfilzomib with induction chemotherapy in pediatric relapsed/refractory acute lymphoblastic leukemia. Pediatr Blood Cancer. 2022 Dec;69(12):e29999. doi: 10.1002/pbc.29999. Epub 2022 Oct 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 27 mg/m2 | — |
| Subject | Carfilzomib | Other / unclassified | 36 mg/m2 | — |
| Subject | Carfilzomib | Other / unclassified | 45 mg/m2 | — |
| Subject | Carfilzomib | Other / unclassified | 56 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Cytarabine | Small molecule | — | Intrathecal |
| Background | Daunorubicin | Small molecule | — | — |
| Background | Dexamethasone | Small molecule | — | — |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | — |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Mitoxantrone | Small molecule | — | — |
| Background | Pegaspargase | Protein / enzyme biologic | — | — |
| Background | Vincristine | Small molecule | — | — |