Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase I/II Study of Ublituximab in Combination With Lenalidomide (Revlimid®) in Patients With B-Cell Lymphoid Malignancies Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy
Verified date | May 2022 |
Source | TG Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether ublituximab in combination with lenalidomide (Revlimid®) is safe and effective in patients with B-Cell Lymphoid Malignancies who have relapsed or are refractory after CD20 directed antibody therapy.
Status | Terminated |
Enrollment | 10 |
Est. completion date | February 7, 2014 |
Est. primary completion date | February 7, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Relapsed or refractory B-cell non-Hodgkins Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) - Participants must have received at least one prior line of therapy with an anti-CD20 antibody (i.e. rituximab, ofatumumab, etc.) or an anti-CD20 antibody containing regimen - Measurable or evaluable Disease - Eastern Cooperative Oncology Group performance status 0, 1 or 2 - Participants ineligible for high dose or combination chemotherapy + stem cell transplant - No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology - All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist® Exclusion Criteria: - Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry - Prior autologous or allogeneic stem cell transplantation within 6 months of study entry - History of severe hypersensitivity or anaphylaxis to prior murine or mouse/human chimeric antibodies, or to any component of ublituximab, or with prior lenalidomide or thalidomide - Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements - History of deep vein thrombosis (DVT) or pulmonary embolus (PE) in the six months prior to Day 1 of Cycle 1 - Pregnant women |
Country | Name | City | State |
---|---|---|---|
United States | TG Therapeutics Investigational Trial Site | Bethesda | Maryland |
United States | TG Therapeutics Investigational Trial Site | Huntsville | Alabama |
Lead Sponsor | Collaborator |
---|---|
TG Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pharmacokinetic profile including Peak Plasma Concentration (Cmax) | Up to 6 months | ||
Primary | Maximum Tolerated Dose acceptable for participants | The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board | 4 weeks | |
Secondary | Efficacy | Efficacy will include overall response rate and duration of response | After 8 weeks and then every 12 weeks |
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