Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/15/2018 |
| Start Date: | January 2015 |
| End Date: | November 2019 |
A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
This study evaluates the addition of ublituximab, a novel monoclonal antibody, to ibrutinib
compared to ibrutinib alone in previously treated Chronic Lymphocytic Leukemia (CLL) patients
with high-risk cytogenetic features. Half of the participants will receive ublituximab in
combination with ibrutinib, while the other half will receive ibrutinib alone.
compared to ibrutinib alone in previously treated Chronic Lymphocytic Leukemia (CLL) patients
with high-risk cytogenetic features. Half of the participants will receive ublituximab in
combination with ibrutinib, while the other half will receive ibrutinib alone.
Inclusion Criteria:
- Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
- At least one high-risk cytogenetic feature defined by the presence of 17p deletion,
11q deletion and/or p53 mutation
- 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)
- Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's
tyrosine kinase (BTK)
We found this trial at
121
sites
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