Clinical trial · Interventional
VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy
NCT03400176CI-TRIAL-00089827terminatedPhase 1Results 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): Business reasons
Summary
Brief summary (as posted)
Patients enrolled to the study had chronic lymphocytic leukemia (CLL) and received ibrutinib. Patients had either received ibrutinib for one year without having had a complete response or patients developed a resistance mutation to ibrutinib. This study had two parts, a dose escalation part and a dose expansion part.
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 (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ibrutinib | Drug | Ibrutinib | ALIAS |
| VAY736 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.
- interventionNames
- Drug: VAY736
- Drug: ibrutinib
- type
- EXPERIMENTAL
- label
- Dose expansion
- description
- Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.
- interventionNames
- Drug: VAY736
- Drug: ibrutinib
Primary outcomes (6)
- measure
- Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1 (Escalation Only)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of CLL per the WHO classification * At least 18 years of age * Lack of a complete response after receiving ibrutinib for \> 1 year OR presence of known ibrutinib resistance mutation * Actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm) Exclusion Criteria: * Known history of HIV * Active hepatitis B or C infection * Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.
References
Publications (1)
- DERIVEDKipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536. PMID 34398557