Description:
Patients enrolled to the study will have chronic lymphocytic leukemia (CLL) and are actively
receiving ibrutinib. Patients will have either been receiving ibrutinib for one year without
having had a complete response or patients will have developed a resistance mutation to
ibrutinib. This study will have two parts, a dose escalation part and a dose expansion part.
In the dose escalation part, the maximum tolerated dose (MTD) of the combination of VAY736
with ibrutinib will be determined. Once determined, the dose expansion part of the study will
begin.
Title
- Brief Title: VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
- Official Title: Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy
Clinical Trial IDs
- ORG STUDY ID:
CVAY736Y2102
- NCT ID:
NCT03400176
Conditions
- Chronic Lymphocytic Leukemia (CLL)
Interventions
Drug | Synonyms | Arms |
---|
VAY736 | | Dose Escalation |
ibrutinib | Imbruvica | Dose Escalation |
Purpose
Patients enrolled to the study will have chronic lymphocytic leukemia (CLL) and are actively
receiving ibrutinib. Patients will have either been receiving ibrutinib for one year without
having had a complete response or patients will have developed a resistance mutation to
ibrutinib. This study will have two parts, a dose escalation part and a dose expansion part.
In the dose escalation part, the maximum tolerated dose (MTD) of the combination of VAY736
with ibrutinib will be determined. Once determined, the dose expansion part of the study will
begin.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation | Experimental | Increasing doses of VAY736 in combination with a fixed dose of ibrutinib. | |
Dose expansion | Experimental | Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation. | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | DLT rate |
Time Frame: | 1 year |
Safety Issue: | |
Description: | To determine the incidence of DLTs. |
Secondary Outcome Measures
Measure: | Overall Response Rate (ORR) |
Time Frame: | Two years |
Safety Issue: | |
Description: | To determine preliminary antitumor activity of the combination. |
Measure: | Time to progression (TTP) |
Time Frame: | Two years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- Ibrutinib
- VAY736
- Chronic lymphocytic leukemia
- CLL
- Bruton's Tyrosine Kinase
- BTK mutation
Last Updated
July 27, 2021