EUCTR2017-000129-12-ITActive, not recruitingPhase 1
Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma - Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell Lymphoma
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 287
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Disease-Related
- •Pathologically confirmed MCL (in tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR).
- •At least 1 measurable site of disease on cross-sectional imaging that is =2.0 cm in the longest diameter and measurable in 2 perpendicular dimensions per CT
- •At least 1, but no more than 5, prior treatment regimens for MCL
- •Failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen
- •Subjects must have adequate fresh or paraffin embedded tissue.
- •Adequate hematologic function
- •Adequate hepatic and renal function
- •Demographic
- •Men and women = 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 109
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 178
Exclusion Criteria
- •Disease-Related
- •History or current evidence of central nervous system lymphoma
- •Concurrent Conditions
- •Concurrent enrollment in another therapeutic investigational study or prior therapy with ibrutinib or other BTK inhibitors
- •Prior treatment with venetoclax or other BCL2 inhibitors
- •Anticancer therapy including chemotherapy, radiotherapy, small molecule and investigational agents =21 days prior to receiving the first dose of study drug
- •Treatment with any of the following within 7 days prior to the first dose of study drug:
- •o moderate or strong cytochrome P450 3A (CYP3A) inhibitors
- •o moderate or strong CYP3A inducers
Investigators
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