Clareo Health | Study to Assess Effect of Oral Venetoclax Tablet in Combination With Oral Ibrutinib Capsule on Best Overall Response of Complete Response in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma
Study to Assess Effect of Oral Venetoclax Tablet in Combination With Oral Ibrutinib Capsule on Best Overall Response of Complete Response in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Pathologically confirmed Mantle Cell Lymphoma (MCL) (tumor tissue) by local testing.
At least 1 measurable site of disease on cross-sectional imaging that is \>= 2.0 centimeters (cm) in the longest diameter and measurable in 2 perpendicular dimensions per Computed Tomography (CT).
At least 1, but no more than 5, prior treatment regimens for MCL including at least 1 prior rituximab/anti-CD20 containing regimen.
Failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
You may not be if
Prior therapy with ibrutinib or other Bruton Tyrosine Kinase (BTK) inhibitors.
History of other malignancies, except:
* Malignancy treated with curative intent and with no known active disease present for \>= 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated carcinoma in situ without evidence of disease.
History or current evidence of central nervous system lymphoma.
Treatment with any of the following within 7 days prior to the first dose of study drug:
* Moderate or strong cytochrome P450 3A (CYP3A) inhibitors.
* Moderate or strong CYP3A inducers.
* Anticancer therapy, including chemotherapy, radiotherapy, small molecule, and investigational agents, and/or monoclonal antibody \<=21 days prior to the first dose of study drug.
