Clinical trial · Interventional
Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
A Phase 2 Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
NCT04016805CI-TRIAL-00068220terminatedPhase 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)
Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.
Conditions
Conditions (1)
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 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acalabrutinib Oral Capsule | Drug | Acalabrutinib | ALIAS |
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Ublituximab | Drug | — | UNRESOLVED |
| Umbralisib | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ublituximab + umbralisib + ibrutinib
- description
- Participants were administered with ublituximab, 900 milligrams (mg), intravenous (IV) infusion once every cycle through cycle 6, then every three cycles upto 24 cycles; umbralisib, 800 mg, oral tablet, daily through Cycles 1-24; ibrutinib oral tablet daily (1 Cycle = 28 days).
- interventionNames
- Drug: Ublituximab
- Drug: Umbralisib
- Drug: Ibrutinib
- type
- EXPERIMENTAL
- label
- ublituximab + umbralisib + venetoclax
- description
- Participants were administered with ublituximab, 900 milligrams (mg), intravenous (IV) infusion once every cycle through cycle 6, then every three cycles upto 24 cycles; umbralisib, 800 mg, oral tablet, daily through Cycles 1-24; venetoclax oral tablet daily (1 Cycle = 28 days).
- interventionNames
- Drug: Ublituximab
- Drug: Umbralisib
- Drug: Venetoclax
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with Chronic Lymphocytic Leukemia (CLL) who have been on treatment for at least 6 months * Minimal Residual Disease positive at screening * Adequate organ system function as specified in the protocol * Ability to follow protocol procedures. Exclusion Criteria: * Participants receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1. * Participants with a known histological transformation * Active Hepatitis B or Hepatitis C.
References
Publications (0)
Data not yet available
No reference posted for this study.