Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT02303821 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 141
Last updated 2025-06-04
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
- Acute Lymphoblastic Leukemia (ALL)
Interventions
- DRUG
- DRUG
- DRUG
-
Mitoxantrone
- DRUG
-
PEG-asparaginase
- DRUG
-
Vincristine
- DRUG
-
Intrathecal (IT) Methotrexate
- DRUG
-
Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)
- DRUG
-
6-Mercaptopurine
- DRUG
- DRUG
- DRUG
-
Daunorubicin
Sponsors & Collaborators
-
Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) - Study Design & Execution Collaborator
collaborator UNKNOWN -
Innovative Therapies For Children with Cancer Consortium
collaborator OTHER - lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Month
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-02-16
- Primary Completion
- 2024-06-28
- Completion
- 2024-06-28
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
Study Locations
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