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.
Completed
Phase 3
| Drug | Synonyms | Arms |
|---|---|---|
| Ublituximab | Ublituximab + ibrutinib | |
| ibrutinib | IMBRUVICA | Ibrutinib |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Ublituximab + ibrutinib | Experimental | Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose |
|
| Ibrutinib | Active Comparator | - Ibrutinib: Fixed oral daily dose |
|
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)
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Overall Response Rate |
| Time Frame: | Every 8-12 weeks, up to 2 years |
| Safety Issue: | |
| Description: | To assess the overall response rate (ORR) in patients with Chronic Lymphocytic Leukemia treated with ublituximab in combination with ibrutinib compared to ibrutinib alone |
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | TG Therapeutics, Inc. |
August 24, 2021
