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NCT01471782 · ClinicalTrials.gov registry record · Phase 1
Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
A Phase 1 study of Acute Lymphoblastic Leukemia, sponsored by Amgen Research (Munich).
- Completed
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT01471782: Completed Phase 1 study of Acute Lymphoblastic Leukemia, sponsored by Amgen Research (Munich).
NCT01471782 is a Phase 1 study of Acute Lymphoblastic Leukemia that has completed, run by Amgen Research (Munich). The registered enrollment target is 93 participants, below the 381-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01471782, a Phase 1 study of Acute Lymphoblastic Leukemia, has completed, sponsored by Amgen Research (Munich).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and to assess whether this dose of blinatumomab is effective.
Primary Outcome
The maximum tolerated dose (MTD) was defined as one or fewer out of 6 participants experiencing a dose limiting toxicity (DLT) or the maximum administered dose (MAD). A dose limiting toxicity is any Grade ≥ 3 adverse event related to study drug, Grade 3 fatigue, headache, insomnia, fever, hypotension or infection were not considered dose limiting toxicities. Laboratory parameters of Grade ≥ 3 but not considered as clinically relevant and/or responding to routine medical management, thrombocytop
Conditions Studied
Interventions
- BIOLOGICAL Blinatumomab
Study Locations (20)
Other
- St. Anna Kinderspital - Vienna
- (CHU Besancon) Hopital Saint-Jaques - Besançon
- Hôpital de la Timone (Enfants) - Marseille
- Hopital Robert Debré (AP-HP) - Paris
- Charité Campus Virchow Klinikum, Otto-Heubner-Centrum (OHC) für Kinder- und Jugendmedizin - Berlin
- Universitätsklinikum Düsseldorf - Düsseldorf
- Universitätsklinikum Essen - Essen
- Klinikum der Johann Wolfgang Goethe-Universität Frankfurt/Main - Frankfurt am Main
Texas
- UT Southwestern Medical Center - Dallas
- Texas Children's Cancer Center/ Baylor - Houston
Colorado
- Children's Hospital Denver - Aurora
Georgia
- Children's Healthcare of Atlanta at Egleston - Atlanta
Missouri
- Washington University - St Louis
New York
- Memorial Sloan Kettering - New York
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2012-01 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
What the finished NCT01471782 record still lists
NCT01471782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 381-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Blinatumomab is the first listed.
NCT01471782 names 20 study sites across 12 states, led by Other, Texas, Colorado.
Frequently Asked Questions
What is clinical trial NCT01471782 about?
NCT01471782 is a clinical study titled "Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia". The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and to assess whether this dose of blinatumomab is effective.
What is the current status of trial NCT01471782?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2012-01. Estimated completion is 2016-05.
What conditions does trial NCT01471782 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT01471782?
The interventions under investigation include: Blinatumomab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01471782?
This trial is sponsored by Amgen Research (Munich), which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01471782 being conducted?
This trial has 20 study locations across Colorado, Georgia, Missouri, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Lymphoblastic Leukemia
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 NCT01471782's enrollment target sits among peer trials
93 51st of 131 higher than 80 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphoblastic Leukemia 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.
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