Clinical trial · Interventional
Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
NCT03379051CI-TRIAL-00060468terminatedPhase 1 / Phase 2ClinicalTrials.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)
Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL
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 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Ublituximab | Biological | — | UNRESOLVED |
| Umbralisib | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ublituximab + Umbralisib + Venetoclax
- description
- Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose
- interventionNames
- Drug: Venetoclax
- Drug: Umbralisib
- Biological: Ublituximab
- type
- EXPERIMENTAL
- label
- Ublituximab + Umbralisib + Lenalidomide
- description
- Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days
- interventionNames
- Drug: Umbralisib
- Biological: Ublituximab
- Drug: Lenalidomide
Primary outcomes (1)
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 Non-Hodgkin's Lymphoma * 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 * Known histological transformation from CLL to an aggressive lymphoma (Richter's)
References
Publications (1)
- DERIVEDHill BT, Ma S, Zent CS, Baran AM, Wallace DS, Advani A, Winter A, Winter J, Gordan L, Karmali R, Liesveld JL, Mulford DA, Rowland C, Bui A, Sportelli P, Miskin HP, Weiss MS, Friedberg JW, Barr PM. Response-adapted, time-limited venetoclax, umbralisib, and ublituximab for relapsed/refractory chronic lymphocytic leukemia. Blood Adv. 2024 Jan 23;8(2):378-387. doi: 10.1182/bloodadvances.2023010693. PMID 37871300