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NCT03160079 · ClinicalTrials.gov registry record · Phase 1
Blinatumomab & Pembrolizumab for Adults With Relapsed/Refractory B-cell ALL With High Marrow Lymphoblasts
A Phase 1 study of B-Cell Acute Lymphoblastic Leukemia, Adult, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 4
- Study locations
NCT03160079: Completed Phase 1 study of B-Cell Acute Lymphoblastic Leukemia, Adult, sponsored by University of California, San Diego.
NCT03160079 is a Phase 1 study of B-Cell Acute Lymphoblastic Leukemia, Adult that has completed, run by University of California, San Diego. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03160079, a Phase 1 study of B-Cell Acute Lymphoblastic Leukemia, Adult, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a Phase I/II study of blinatumomab in combination with pembrolizumab in adult patients with relapsed or refractory B-lineage ALL (B-ALL). The primary objective of this study is to determine if the addition of pembrolizumab to blinatumomab improves the Complete Response Rate (CR) and Complete Remission with Partial Hematologic Recovery (CRh) relative to blinatumomab alone in adult subjects with relapsed or refractory B-cell acute lymphoblastic leukemia with high bone marrow lymphoblast percentage (\>50% lymphoblasts).
Primary Outcome
Best overall response rate (ORR) with the combination of blinatumomab and pembrolizumab in adult subjects with relapsed or refractory B-cell acute lymphoblastic leukemia will be defined as the Complete Response (CR) rate plus the Complete Response with Hematologic Recovery (CRh) rate after treatment of combination therapy. According to the National Comprehensive Cancer Network (NCCN) Guidelines for Acute Lymphoblastic Leukemia (version 1, 2015), CR is defined as \<5% lymphoblast in the bone marr
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG blinatumomab
Study Locations (4)
California
- UCSF Fresno Community Cancer Institute - Clovis
- UC San Diego Moores Cancer Center - La Jolla
- UC Irvine Health Chao Family Comprehensive Cancer Center - Orange
- UCSF Comprehensive Cancer Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-08-04 |
| Est. Completion | 2023-06-23 |
| Phase | Phase 1 |
What the finished NCT03160079 record still lists
NCT03160079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 1 condition, with B-Cell Acute Lymphoblastic Leukemia, Adult appearing as the primary indexed condition, and to 2 interventions - of which pembrolizumab is the first listed.
NCT03160079 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03160079 about?
NCT03160079 is a clinical study titled "Blinatumomab & Pembrolizumab for Adults With Relapsed/Refractory B-cell ALL With High Marrow Lymphoblasts". This is a Phase I/II study of blinatumomab in combination with pembrolizumab in adult patients with relapsed or refractory B-lineage ALL (B-ALL). The primary objective of this study is to determine if the addition of pembrolizumab to blinatumomab improves the Complete Response Rate (CR) and Complete...
What is the current status of trial NCT03160079?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2017-08-04. Estimated completion is 2023-06-23.
What conditions does trial NCT03160079 study?
This clinical trial studies the following conditions: B-Cell Acute Lymphoblastic Leukemia, Adult.
What interventions are being tested in trial NCT03160079?
The interventions under investigation include: pembrolizumab (DRUG), blinatumomab (DRUG).
Who is sponsoring clinical trial NCT03160079?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03160079 being conducted?
This trial has 4 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03160079's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
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