Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Public ClinicalTrials.gov record NCT02303821. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02303821
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 141 participants
Conditions and interventions
Conditions
Interventions
- 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 Drug
Drug
Eligibility (public fields only)
- Age range
- 1 Month to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 16, 2015 (Actual)
- Primary completion
- Jun 28, 2024 (Actual)
- Completion
- Jun 28, 2024 (Actual)
- Last update posted
- Jun 4, 2025
2015 – 2024
United States locations
- U.S. sites
- 22
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Francisco Benioff Childrens Hospital Oakland | Oakland | California | 94609 | — |
| Childrens Hospital of Orange County | Orange | California | 92868 | — |
| Childrens Hospital Colorado | Aurora | Colorado | 80045 | — |
| Childrens Healthcare of Atlanta, Egleston | Atlanta | Georgia | 30322 | — |
| Lurie Childrens Hospital of Chicago | Chicago | Illinois | 60611 | — |
| The Sidney Kimmel Comprehensive Cancer Center at John Hopkins | Baltimore | Maryland | 21231 | — |
| Childrens Hospital and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | — |
| Childrens Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| Childrens Hospital of New York Presbyterian | New York | New York | 10032 | — |
| Levine Childrens Hospital at Carolinas Medical Center d/b/a Atrium Health | Charlotte | North Carolina | 28203 | — |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Nationwide Childrens Hospital | Columbus | Ohio | 43205 | — |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4318 | — |
| Saint Judes Childrens Research Hospital | Memphis | Tennessee | 38105 | — |
| Childrens Medical Center | Dallas | Texas | 75390 | — |
| Texas Childrens Hospital West Tower | Houston | Texas | 77030 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-4493 | — |
| University of Utah Medical Center Primary Childrens Medical Center | Salt Lake City | Utah | 84113 | — |
| West Virginia University Medicine Childrens | Morgantown | West Virginia | 60637 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 100 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02303821, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2025 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02303821 live on ClinicalTrials.gov.