Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Mantle Cell Lymphoma (MCL)
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
Mantle Cell Lymphoma (MCL) is a form of Non-Hodgkin Lymphoma (NHL - cancer of the lymphatic system in blood) where cells from outer edge of the lymph nodes, called mantle zone become cancerous. In Jap...
Detailed Description
Safety and efficacy data through 09 February 2022 are included in the interim analysis.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2025
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04477486
Start Date
September 23 2020
End Date
May 28 2025
Last Update
July 9 2025
Active Locations (12)
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1
NHO Nagoya Medical Center /ID# 221958
Nagoya, Aichi-ken, Japan, 460-0001
2
Aichi Cancer Center Hospital /ID# 221565
Nagoya, Aichi-ken, Japan, 464-8681
3
Kyushu University Hospital /ID# 223299
Fukuoka, Fukuoka, Japan, 812-8582
4
Hokkaido University Hospital /ID# 221662
Sapporo, Hokkaido, Japan, 060-8648