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NCT02961881 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma
A Phase 1 study of Non-Hodgkin's Lymphoma, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 17
- Study locations
NCT02961881: Completed Phase 1 study of Non-Hodgkin's Lymphoma, sponsored by Amgen.
NCT02961881 is a Phase 1 study of Non-Hodgkin's Lymphoma that has completed, run by Amgen. The registered enrollment target is 35 participants, below the 221-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (84% lower). The trial reports 17 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02961881, a Phase 1 study of Non-Hodgkin's Lymphoma, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 17
- Study locations
Study Summary
Primary Objective: • To evaluate the safety and tolerability of subcutaneous (SC) blinatumomab dose administrations Secondary Objectives: * To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC administrations * To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered subcutaneously * To determine the incidence of anti-blinatumomab antibody formation following SC administration * To evaluate efficacy response following treatment with SC blinatumomab administration Exploratory Objective: * To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as cytokine profiles during SC administration * To evaluate efficacy response following treatment with SC blinatumomab administration using Lugano criteria if positron emission tomography-computed tomography (PET/CT) is used for evaluation
Primary Outcome
The occurrence of any of the following toxicities during the DLT evaluation period was considered a DLT, if judged by the investigator to be related to the administration of blinatumomab: * Death * Any toxicity, regardless of grade, that lead to a participant's removal from the study by the investigator and/or sponsor * Persistent Common Terminology Criteria for Adverse Events (CTCAE) grade \>/= 2 non-hematologic adverse events (AEs) that were deemed intolerable by the participant or the treati
Conditions Studied
Interventions
- DRUG blinatumomab
Study Locations (17)
Other
- Hopital Henri Mondor - Créteil Cedex
- Hopital Saint Louis - Paris
- Universitaetsklinikum Carl Gustav Carus - Dresden
- Universitätsklinikum Frankfurt/Main - Frankfurt am Main
- Universitatsklinikum Ulm - Ulm
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Bergamo
- Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi - Bologna
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Brescia
- IRCCS Ospedale San Raffaele - Milan
- IRCCS Istituto Clinico Humanitas - Rozzano MI
- Leicester Royal Infirmary - Leicester
Victoria
- Epworth Healthcare - East Melbourne
- St Vincents Hospital Melbourne - Fitzroy
California
- City of Hope National Medical Center - Duarte
Illinois
- Rush University Medical Center - Chicago
New Jersey
- Hackensack University Medical Center - Hackensack
New South Wales
- Concord Repatriation General Hospital - Concord
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-09-18 |
| Est. Completion | 2021-09-02 |
| Phase | Phase 1 |
What the finished NCT02961881 record still lists
NCT02961881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 221-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Non-Hodgkin's Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which blinatumomab is the first listed.
NCT02961881 lists 17 locations in 6 states (Other, Victoria, California).
Frequently Asked Questions
What is clinical trial NCT02961881 about?
NCT02961881 is a clinical study titled "A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma". Primary Objective: • To evaluate the safety and tolerability of subcutaneous (SC) blinatumomab dose administrations Secondary Objectives: * To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC administrations * To estimate the maximum tolerated dose (MTD) tested for blinatu...
What is the current status of trial NCT02961881?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2017-09-18. Estimated completion is 2021-09-02.
What conditions does trial NCT02961881 study?
This clinical trial studies the following conditions: Non-Hodgkin's Lymphoma.
What interventions are being tested in trial NCT02961881?
The interventions under investigation include: blinatumomab (DRUG).
Who is sponsoring clinical trial NCT02961881?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02961881 being conducted?
This trial has 17 study locations across California, Illinois, New Jersey, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02961881's enrollment target sits among peer trials
35 38th of 63 higher than 26 of 63 other Non-Hodgkin's Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin's Lymphoma 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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