NCT02535286

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

September 18, 2015

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2021

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

6.1 years

First QC Date

August 24, 2015

Last Update Submit

October 19, 2022

Conditions

Chronic Lymphocytic LeukemiaRichter Syndrome

Outcome Measures

Primary Outcomes (1)

  • Determine Acceptable Adverse Events That Are Related to Treatment

    To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

    6 months of therapy

Secondary Outcomes (1)

  • Overall Response Rate

    Up to 1 year

Study Arms (1)

TG-1501 + Ublituximab + Umbralisib

EXPERIMENTAL

Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals

Drug: UmbralisibBiological: ublituximabBiological: TG-1501

Interventions

UmbralisibDRUG

A once daily oral agent

Also known as: TGR-1202
TG-1501 + Ublituximab + Umbralisib
ublituximabBIOLOGICAL

IV anti-CD20 monoclonal antibody

Also known as: TG-1101
TG-1501 + Ublituximab + Umbralisib
TG-1501BIOLOGICAL

IV immunotherapy for cancer

TG-1501 + Ublituximab + Umbralisib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
  • Refractory to or relapsed after at least 1 prior treatment regimen
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

You may not qualify if:

  • Any major surgery, chemotherapy or immunotherapy within the last 14 days
  • Known hepatitis B virus, hepatitis C virus or HIV infection
  • Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

TG Therapeutics Investigational Trial Site

New York, New York, 10065, United States

Location

TG Therapeutics Investigational Trial Site

Durham, North Carolina, 27710, United States

Location

TG Therapeutics Investigational Trial Site

Philadelphia, Pennsylvania, 19104, United States

Location

TG Therapeutics Investigational Trial Site

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

umbralisibublituximab

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anthony R. Mato, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2015

First Posted

August 28, 2015

Study Start

September 18, 2015

Primary Completion

November 4, 2021

Study Completion

November 4, 2021

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

US(4)