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

Sponsor

TG Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02006485

Collaborator

(none)

160

Enrollment

Locations

Arms

69.6

Actual Duration (Months)

26.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Non-Hodgkin's Lymphoma	Drug: Ublituximab + TGR-1202 Drug: Ublituximab + TGR-1202 + ibrutinib Drug: Ublituximab + TGR-1202 + bendamustine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Dec 13, 2013

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ublituximab + TGR-1202 Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose	Drug: Ublituximab + TGR-1202 Ublituximab IV infusion TGR-1202 oral daily dose
Experimental: Ublituximab + TGR-1202 + ibrutinib 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	Drug: Ublituximab + TGR-1202 + ibrutinib Ublituximab IV infusion TGR-1202 oral daily dose Ibrutinib oral daily dose Other Names: Imbruvica
Experimental: Ublituximab + TGR-1202 + bendamustine 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	Drug: Ublituximab + TGR-1202 + bendamustine Ublituximab IV infusion TGR-1202 oral daily dose Bendamustine IV infusion Other Names: Treanda

Arm

Intervention/Treatment

Experimental: Ublituximab + TGR-1202

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

Drug: Ublituximab + TGR-1202

Ublituximab IV infusion TGR-1202 oral daily dose

Experimental: Ublituximab + TGR-1202 + ibrutinib

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

Drug: Ublituximab + TGR-1202 + ibrutinib

Ublituximab IV infusion TGR-1202 oral daily dose Ibrutinib oral daily dose

Other Names:

Imbruvica

Experimental: Ublituximab + TGR-1202 + bendamustine

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

Drug: Ublituximab + TGR-1202 + bendamustine

Ublituximab IV infusion TGR-1202 oral daily dose Bendamustine IV infusion

Other Names:

Treanda

Outcome Measures

Primary Outcome Measures

Maximum Tolerated Dose acceptable for participants [28 days (1 cycle of therapy)]
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary Outcome Measures

Overall Response Rate [Up to 1 year]
To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with TGR-1202

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TG Therapeutics Investigational Trial Site	Huntsville	Alabama	United States	35805
2	TG Therapeutics Investigational Trial Site	Jonesboro	Arkansas	United States	72401
3	TG Therapeutics Investigational Trial Site	Duarte	California	United States	91010
4	TG Therapeutics Investigational Trial Site	Atlanta	Georgia	United States	30322
5	TG Therapeutics Investigational Trial Site	Omaha	Nebraska	United States	68198
6	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

TG Therapeutics, Inc.

Investigators

Study Chair: Nathan Fowler, MD, M.D. Anderson Cancer Center
Study Chair: Susan O'Brien, MD, University of California Irvine Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

TG Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT02006485

Other Study ID Numbers:

UTX-TGR-103

First Posted:

Dec 10, 2013

Last Update Posted:

Nov 5, 2019

Last Verified:

Nov 1, 2019

Additional relevant MeSH terms:

Leukemia, Lymphocytic, Chronic, B-Cell

Bendamustine Hydrochloride

Antibodies, Monoclonal

Study Results

No Results Posted as of Nov 5, 2019