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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: Completed Phase 1 study of Acute Lymphoblastic Leukemia (ALL), sponsored by Amgen.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are AEs that occurred after the start of study treatment and up to the end of the study or 30 days of the last study treatment, whichever is earlier. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. Treatment-relat

Conditions Studied

Acute Lymphoblastic Leukemia (ALL)

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

FieldValue
Enrollment Target 141 participants
Start Date 2015-02-16
Est. Completion 2024-06-28
Phase Phase 1
Amgen

558 total trials

What the finished NCT02303821 record still lists

NCT02303821 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 6,297-participant average among 16 other Acute Lymphoblastic Leukemia (ALL) trials with a reported enrollment target (98% lower).

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 names 20 study sites across 15 states, led by 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.

Learn More About Clinical Trials

Similar trials for Acute Lymphoblastic Leukemia (ALL)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02303821's enrollment target sits among peer trials

141 3rd of 16 higher than 14 of 16 other Acute Lymphoblastic Leukemia (ALL) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia (ALL) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02303821, the US trial registry maintained by the National Library of Medicine. NCT02303821 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.