Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT02303821 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Dexamethasone
- DRUG Vincristine
- DRUG Carfilzomib
- DRUG Mitoxantrone
- DRUG PEG-asparaginase
Study Locations (20)
Ohio
- Cincinnati Childrens Hospital Medical Center — Cincinnati
- The Cleveland Clinic Foundation — Cleveland
- Nationwide Childrens Hospital — Columbus
Texas
- Childrens Medical Center — Dallas
- Texas Childrens Hospital West Tower — Houston
- University of Texas Health Science Center at San Antonio — San Antonio
California
- University of California San Francisco Benioff Childrens Hospital Oakland — Oakland
- Childrens Hospital of Orange County — Orange
Colorado
- Childrens Hospital Colorado — Aurora
Georgia
- Childrens Healthcare of Atlanta, Egleston — Atlanta
Illinois
- Lurie Childrens Hospital of Chicago — Chicago
Maryland
- The Sidney Kimmel Comprehensive Cancer Center at John Hopkins — Baltimore
Minnesota
- Childrens Hospital and Clinics of Minnesota — Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2015-02-16 |
| Est. Completion | 2024-06-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02303821
The ClinicalTrials.gov registry entry for NCT02303821 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute Lymphoblastic Leukemia (ALL) appearing as the primary indexed condition, and to 5 interventions — of which Dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02303821 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Ohio, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02303821 about?
NCT02303821 is a clinical study titled "Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia". 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 ...
What is the current status of trial NCT02303821?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 141 participants. The study started on 2015-02-16. Estimated completion is 2024-06-28.
What conditions does trial NCT02303821 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia (ALL). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02303821?
The interventions under investigation include: Dexamethasone (DRUG), Vincristine (DRUG), Carfilzomib (DRUG), Mitoxantrone (DRUG), PEG-asparaginase (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02303821?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02303821 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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