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NCT02268851 · ClinicalTrials.gov registry record · Phase 1

A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL

A Phase 1 study of Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 1
Development phase
45
Enrollment target
5
Study locations

NCT02268851 is a Phase 1 study of Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 45 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (57% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT02268851, a Phase 1 study of Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
45 participants
Enrollment target
5
Study locations

Study Summary

This research study will be evaluating the safety and efficacy of a study drug called TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.

Conditions Studied

Mantle Cell Lymphoma Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Interventions

  • DRUG Ibrutinib
  • DRUG TGR-1202

Study Locations (5)

Massachusetts

  • Dana Farber Cancer Institute - Boston
  • Beth Israel Deaconness Medical Center - Boston

California

  • Pacific Cancer Care - Monterey

Connecticut

  • St. Francis Hospital and Cancer Center - Hartford

Maine

  • Eastern Maine Medical Center/ Northern Light Cancer Care - Brewer

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2014-11
Est. Completion 2022-10
Phase Phase 1

Sponsor

Dana-Farber Cancer Institute

781 total trials

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What the Registry Record Tells You About NCT02268851

The ClinicalTrials.gov registry entry for NCT02268851 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (57% lower). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Ibrutinib is the first listed.

NCT02268851 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Massachusetts, California, Connecticut.

Frequently Asked Questions

What is clinical trial NCT02268851 about?

NCT02268851 is a clinical study titled "A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL". This research study will be evaluating the safety and efficacy of a study drug called TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle Cell Lymphoma (MCL) that has com...

What is the current status of trial NCT02268851?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2014-11. Estimated completion is 2022-10.

What conditions does trial NCT02268851 study?

This clinical trial studies the following conditions: Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

What interventions are being tested in trial NCT02268851?

The interventions under investigation include: Ibrutinib (DRUG), TGR-1202 (DRUG).

Who is sponsoring clinical trial NCT02268851?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02268851 being conducted?

This trial has 5 study locations across California, Connecticut, Maine, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.