Ublituximab + Ibrutinib in Select B-cell Malignancies
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2019 |
| Start Date: | December 2013 |
| End Date: | May 2019 |
A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies
The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in
combination with Ibrutinib in patients with advanced hematologic malignancies.
combination with Ibrutinib in patients with advanced hematologic malignancies.
Inclusion Criteria:
- Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic
Leukemia (CLL) enrollment arm is now closed.
- Refractory to or relapsed after at least 1 prior treatment regimen
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion Criteria:
- Any major surgery, chemotherapy or immunotherapy within the last 21 days
- Known hepatitis B virus, hepatitis C virus or HIV infection
- Autologous hematologic stem cell transplant within 3 months of study entry. Prior
Allogeneic hematologic stem cell transplant is excluded.
- Richter's transformation, prolymphocytic leukemia or primary central nervous system
lymphoma
We found this trial at
18
sites
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