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COMPLETED Phase 1

Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

NCT02535286 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

Interventions

  • DRUG Umbralisib
  • BIOLOGICAL ublituximab
  • BIOLOGICAL TG-1501

Study Locations (4)

New York

  • TG Therapeutics Investigational Trial Site — New York

North Carolina

  • TG Therapeutics Investigational Trial Site — Durham

Pennsylvania

  • TG Therapeutics Investigational Trial Site — Philadelphia

Washington

  • TG Therapeutics Investigational Trial Site — Seattle

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2015-09-18
Est. Completion 2021-11-04
Phase Phase 1

Sponsor

TG Therapeutics

45 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02535286

The ClinicalTrials.gov registry entry for NCT02535286 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TG Therapeutics, which has 45 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Umbralisib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02535286 reports 4 study locations spanning 4 distinct geographic areas — top geographies include New York, North Carolina, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02535286 about?

NCT02535286 is a clinical study titled "Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation". The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

What is the current status of trial NCT02535286?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2015-09-18. Estimated completion is 2021-11-04.

What conditions does trial NCT02535286 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Richter Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02535286?

The interventions under investigation include: Umbralisib (DRUG), ublituximab (BIOLOGICAL), TG-1501 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02535286?

This trial is sponsored by TG Therapeutics, which has 45 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02535286 being conducted?

This trial has 4 study locations across New York, North Carolina, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial