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NCT02303821 · ClinicalTrials.gov registry record · Phase 1
Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
A Phase 1 study of Acute Lymphoblastic Leukemia (ALL), sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 141
- Enrollment target
- 20
- Study locations
NCT02303821 is a Phase 1 study of Acute Lymphoblastic Leukemia (ALL) that has completed, run by Amgen. The registered enrollment target is 141 participants, below the 6,297-participant average among 16 other Acute Lymphoblastic Leukemia (ALL) trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT02303821, a Phase 1 study of Acute Lymphoblastic Leukemia (ALL), has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 141 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,297-participant average among 16 other Acute Lymphoblastic Leukemia (ALL) trials with a reported enrollment target (98% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT02303821 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Ohio, Texas, California.
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).
What interventions are being tested in trial NCT02303821?
The interventions under investigation include: Dexamethasone (DRUG), Vincristine (DRUG), Carfilzomib (DRUG), Mitoxantrone (DRUG), PEG-asparaginase (DRUG).
Who is sponsoring clinical trial NCT02303821?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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