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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 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. The trial reports 4 study locations across 1 state.

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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).

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

FieldValue
Enrollment Target 16 participants
Start Date 2017-08-04
Est. Completion 2023-06-23
Phase Phase 1

Sponsor

University of California, San Diego

775 total trials

What the Registry Record Tells You About NCT03160079

The ClinicalTrials.gov registry entry for NCT03160079 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.