Clinical trial · Interventional
Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma
A Phase II Study Evaluating the Safety and Efficacy of Umbralisib (TGR-1202) in Combination With Ublituximab in Patients With Treatment Naïve Follicular Lymphoma and Small Lymphocytic Lymphoma
NCT03828448CI-TRIAL-00068180terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic/Business Decision
Summary
Brief summary (as posted)
This is a phase 2, open label study to assess umbralisib in combination with ublituximab in participants with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ublituximab | Drug | — | UNRESOLVED |
| Umbralisib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ublituximab + Umbralisib
- description
- Participants were administered ublituximab, 900 milligrams (mg), intravenous (IV) infusion through Cycles 1-6, Cycles 9 and 12. Participants also received umbralisib, 800 mg, oral tablet, daily through Cycles 1-24. 1 Cycle = 28 days.
- interventionNames
- Drug: Ublituximab
- Drug: Umbralisib
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Up to 22 months
- description
- ORR was defined as sum of participants with partial responses (PR) and complete responses (CR). CR was defined as complete disappearance of all evidence of disease and disease-related symptoms. PR was defined as regression of measurable disease and no new sites of disease. Regression= ≥ 50% decrease in sum of the products of diameters (SPD) of index lesions, with no unequivocal increase in size of other lymph nodes, liver, or spleen.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of FL or SLL. * Measurable disease that requires treatment * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 Exclusion Criteria: * Currently or previously received treatment for their lymphoma * Received wide field radiotherapy within 28 days or limited field radiation within 14 days of Cycle 1 Day 1 * Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection
References
Publications (0)
Data not yet available
No reference posted for this study.