Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies
| Verified date | October 2022 |
| Source | TG Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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: - 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. Prior Allogeneic hematologic stem cell transplant is excluded. - Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma |
| Country | Name | City | State |
|---|---|---|---|
| United States | TG Therapeutics Investigational Trial Site | Austin | Texas |
| United States | TG Therapeutics Investigational Trial Site | Bethesda | Maryland |
| United States | TG Therapeutics Investigational Trial Site | Blacksburg | Virginia |
| United States | TG Therapeutics Investigational Trial Site | Boulder | Colorado |
| United States | TG Therapeutics Investigational Trial Site | Dallas | Texas |
| United States | TG Therapeutics Investigational Trial Site | Fairfax | Virginia |
| United States | TG Therapeutics Investigational Trial Site | Greenville | South Carolina |
| United States | TG Therapeutics Investigational Trial Site | Huntsville | Alabama |
| United States | TG Therapeutics Investigational Trial Site | Memphis | Tennessee |
| United States | TG Therapeutics Investigational Trial Site | Morristown | New Jersey |
| United States | TG Therapeutics Investigational Trial Site | Niles | Illinois |
| United States | TG Therapeutics Investigational Trial Site | Portland | Oregon |
| United States | TG Therapeutics Investigational Trial Site | Santa Barbara | California |
| United States | TG Therapeutics Investigational Trial Site | Springfield | Oregon |
| United States | TG Therapeutics Investigational Trial Site | Tucson | Arizona |
| United States | TG Therapeutics Investigational Trial Site | Tyler | Texas |
| United States | TG Therapeutics Investigational Trial Site | Urbana | Illinois |
| United States | TG Therapeutics Investigational Trial Site | Vancouver | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| TG Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies | To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities | 28 days (1 cycle of therapy) | |
| Secondary | Overall Response Rate | To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with Ibrutinib | Up to 1 year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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