Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies
Status: | Completed |
---|---|
Conditions: | Blood Cancer, Lymphoma, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | December 2012 |
End Date: | October 2014 |
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
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
lenalidomide (Revlimid®) is safe and effective in patients with B-Cell Lymphoid Malignancies
who have relapsed or are refractory after CD20 directed antibody therapy
Inclusion Criteria:
- Relapsed or refractory B-cell non-Hodgkins Lymphoma (NHL), Chronic Lymphocytic
Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
- Patients 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
- Patients 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
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