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Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies

Primary Purpose

Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ublituximab + TGR-1202
Ublituximab + TGR-1202 + ibrutinib
Ublituximab + TGR-1202 + bendamustine
Sponsored by
TG Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved by the Medical Monitor or Study Chair
  • Refractory to or relapsed after at least 1 prior treatment regimen
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Known hepatitis B virus, hepatitis C virus or HIV infection
  • Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months
  • Primary central nervous system lymphoma or known intracranial involvement

Sites / Locations

  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • TG Therapeutics Investigational Trial Site
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Ublituximab + TGR-1202

Ublituximab + TGR-1202 + ibrutinib

Ublituximab + TGR-1202 + bendamustine

Arm Description

Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose

Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose ibrutinib oral daily dose

Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Bendamustine at a fixed IV infusion on Days 1 & 2

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose acceptable for participants
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary Outcome Measures

Overall Response Rate
To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with TGR-1202

Full Information

First Posted
December 5, 2013
Last Updated
November 4, 2019
Sponsor
TG Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02006485
Brief Title
Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies
Official Title
A Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Combination With TGR-1202, a Novel PI3k Delta Inhibitor; and Ibrutinib or Bendamustine, in Patients With B-cell Malignancies.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 13, 2013 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with advanced hematologic malignancies

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ublituximab + TGR-1202
Arm Type
Experimental
Arm Description
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose
Arm Title
Ublituximab + TGR-1202 + ibrutinib
Arm Type
Experimental
Arm Description
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose ibrutinib oral daily dose
Arm Title
Ublituximab + TGR-1202 + bendamustine
Arm Type
Experimental
Arm Description
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Bendamustine at a fixed IV infusion on Days 1 & 2
Intervention Type
Drug
Intervention Name(s)
Ublituximab + TGR-1202
Intervention Description
Ublituximab IV infusion TGR-1202 oral daily dose
Intervention Type
Drug
Intervention Name(s)
Ublituximab + TGR-1202 + ibrutinib
Other Intervention Name(s)
Imbruvica
Intervention Description
Ublituximab IV infusion TGR-1202 oral daily dose Ibrutinib oral daily dose
Intervention Type
Drug
Intervention Name(s)
Ublituximab + TGR-1202 + bendamustine
Other Intervention Name(s)
Treanda
Intervention Description
Ublituximab IV infusion TGR-1202 oral daily dose Bendamustine IV infusion
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose acceptable for participants
Description
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
Time Frame
28 days (1 cycle of therapy)
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with TGR-1202
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved by the Medical Monitor or Study Chair Refractory to or relapsed after at least 1 prior treatment regimen Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: Any major surgery, chemotherapy or immunotherapy within the last 21 days Known hepatitis B virus, hepatitis C virus or HIV infection Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months Primary central nervous system lymphoma or known intracranial involvement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Fowler, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Susan O'Brien, MD
Organizational Affiliation
University of California Irvine Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31558467
Citation
Lunning M, Vose J, Nastoupil L, Fowler N, Burger JA, Wierda WG, Schreeder MT, Siddiqi T, Flowers CR, Cohen JB, Sportelli P, Miskin HP, Weiss MS, O'Brien S. Ublituximab and umbralisib in relapsed/refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. Blood. 2019 Nov 21;134(21):1811-1820. doi: 10.1182/blood.2019002118.
Results Reference
derived
PubMed Identifier
30709431
Citation
Nastoupil LJ, Lunning MA, Vose JM, Schreeder MT, Siddiqi T, Flowers CR, Cohen JB, Burger JA, Wierda WG, O'Brien S, Sportelli P, Miskin HP, Purdom MA, Weiss MS, Fowler NH. Tolerability and activity of ublituximab, umbralisib, and ibrutinib in patients with chronic lymphocytic leukaemia and non-Hodgkin lymphoma: a phase 1 dose escalation and expansion trial. Lancet Haematol. 2019 Feb;6(2):e100-e109. doi: 10.1016/S2352-3026(18)30216-3.
Results Reference
derived

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Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies

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