Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Untreated and Previously Treated Chronic Lymphocytic Leukemia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/14/2018 |
| Start Date: | January 2016 |
| End Date: | November 2020 |
A Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
This study evaluates the combination of ublituximab, a novel monoclonal antibody, and
TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and
compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) patients.
TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and
compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) patients.
Inclusion Criteria:
- Treatment naïve or previously treated Chronic Lymphocytic Leukemia (CLL) requiring
treatment
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion Criteria:
- Any major surgery, chemotherapy or immunotherapy within the last 21 days
- Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
- Autologous hematologic stem cell transplant within 3 months of study entry. Prior
Allogeneic hematologic stem cell transplant is excluded
- Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's
transformation)
- Prior therapy with obinutuzumab and/or chlorambucil or a PI3K delta inhibitor
We found this trial at
118
sites
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