Trials / Terminated
TerminatedNCT01744912
Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies
A 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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- TG Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
The study was intended to be a Phase 1/2 study, however, the study was terminated early and the phase 2 portion was never initiated. A limited number of participants were enrolled in Phase 1 and no maximum tolerated dose (MTD) or Phase 2 dose was identified for the combination of ublituximab and lenalidomide. Thus, Phase 2 data and results are not available to be reported.
Conditions
- Non-Hodgkins Lymphoma
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- B-cell Lymphomas
- Marginal Zone Lymphoma
- Mantle Cell Lymphoma
- Waldenstrom's Macroglobulinemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ublituximab | Ublituximab is a novel monoclonal antibody targeting CD20 |
| DRUG | Lenalidomide | Lenalidomide has both immunomodulatory and anti-angiogenic properties which could confer antitumor and antimetastatic effects |
Timeline
- Start date
- 2012-11-21
- Primary completion
- 2014-02-07
- Completion
- 2014-02-07
- First posted
- 2012-12-07
- Last updated
- 2022-05-11
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01744912. Inclusion in this directory is not an endorsement.