Ublituximab + Ibrutinib in Select B-cell Malignancies
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Ublituximab + ibrutinib Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose |
Drug: Ublituximab
Ublituximab (IV infusion)
Drug: Ibrutinib
Ibrutinib oral daily dose
Other Names:
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Outcome Measures
Primary Outcome Measures
- To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies [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 Ibrutinib
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed.
-
Refractory to or relapsed after at least 1 prior treatment regimen
-
Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion Criteria:
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Any major surgery, chemotherapy or immunotherapy within the last 21 days
-
Known hepatitis B virus, hepatitis C virus or HIV infection
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Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded.
-
Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma
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 | Tucson | Arizona | United States | 85710 |
3 | TG Therapeutics Investigational Trial Site | Santa Barbara | California | United States | 93105 |
4 | TG Therapeutics Investigational Trial Site | Boulder | Colorado | United States | 80303 |
5 | TG Therapeutics Investigational Trial Site | Niles | Illinois | United States | 60714 |
6 | TG Therapeutics Investigational Trial Site | Urbana | Illinois | United States | 61801 |
7 | TG Therapeutics Investigational Trial Site | Bethesda | Maryland | United States | 20817 |
8 | TG Therapeutics Investigational Trial Site | Morristown | New Jersey | United States | 07962 |
9 | TG Therapeutics Investigational Trial Site | Portland | Oregon | United States | 97213 |
10 | TG Therapeutics Investigational Trial Site | Springfield | Oregon | United States | 97477 |
11 | TG Therapeutics Investigational Trial Site | Greenville | South Carolina | United States | 29615 |
12 | TG Therapeutics Investigational Trial Site | Memphis | Tennessee | United States | 38120 |
13 | TG Therapeutics Investigational Trial Site | Austin | Texas | United States | 78705 |
14 | TG Therapeutics Investigational Trial Site | Dallas | Texas | United States | 75230 |
15 | TG Therapeutics Investigational Trial Site | Tyler | Texas | United States | 75702 |
16 | TG Therapeutics Investigational Trial Site | Blacksburg | Virginia | United States | 24060 |
17 | TG Therapeutics Investigational Trial Site | Fairfax | Virginia | United States | 22031 |
18 | TG Therapeutics Investigational Trial Site | Vancouver | Washington | United States | 98684 |
Sponsors and Collaborators
- TG Therapeutics, Inc.
Investigators
- Study Chair: Jeff Sharman, MD, Willamette Valley Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UTX-IB-104