Clinical trial · Interventional
Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation
Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL
NCT02535286CI-TRIAL-00061583completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Richter Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TG-1501 | Biological | — | UNRESOLVED |
| ublituximab | Biological | — | UNRESOLVED |
| Umbralisib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TG-1501 + Ublituximab + Umbralisib
- description
- Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals
- interventionNames
- Drug: Umbralisib
- Biological: ublituximab
- Biological: TG-1501
Primary outcomes (1)
- measure
- Determine Acceptable Adverse Events That Are Related to Treatment
- timeFrame
- 6 months of therapy
- description
- To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
Secondary outcomes (1)
- measure
- Overall Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation * 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 14 days * Known hepatitis B virus, hepatitis C virus or HIV infection * Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)
References
Publications (0)
Data not yet available
No reference posted for this study.