Phase 2
N=13
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
Mantle Cell Lymphoma (MCL)
Bottom Line
View on ClinicalTrials.gov: NCT04477486 ↗Enrolled (actual)
13
Serious AEs
15.4%
Results posted
Jan 2025
Primary outcome: Primary: Percentage of Participants Achieving Best Overall Response of Complete Response (CR), as Assessed by the Independent Review Committee (IRC) — 83.3 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibrutinib (Drug); Venetoclax (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Best Overall Response of Complete Response (CR), as Assessed by the Independent Review Committee (IRC) |
83.3 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Best Overall Response of CR or PR, as Assessed by the IRC |
— | — |
| SECONDARY Percentage of Participants Achieving Best Overall Response of CR as Assessed by the Investigator |
— | — |
| SECONDARY Percentage of Participants Achieving Best Overall Response of CR or PR, as Assessed by the Investigator |
— | — |
| SECONDARY Duration of Response (DOR) for Participants Who Achieved a Best Overall Response of CR or PR, as Assessed by the Investigator |
— | — |
| SECONDARY DOR for Participants Who Achieved a Best Overall Response of CR or PR, as Assessed by the IRC |
— | — |
| SECONDARY Undetectable Minimal Residual Disease (uMRD) in Participants Who Achieve a Best Overall Response of CR as Assessed by the Investigator. |
— | — |
| SECONDARY uMRD in Participants Who Achieve a Best Overall Response of CR as Assessed by IRC. |
— | — |
| SECONDARY Progression-Free Survival (PFS) |
— | — |
| SECONDARY Overall Survival (OS) |
— | — |
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 Japan, MCL accounts for about 3% of all NHL cases. Symptoms of MCL may include enlarged lymph nodes, stomach pain, fever, night sweats, and weight loss. Currently, MCL is not curable with standard therapies. The purpose of this study is to evaluate the safety, efficacy, and effect of venetoclax in combination with ibrutinib on best overall response of complete response in participants with relapsed (return of disease) or refractory (not responding to treatment) (R/R) MCL.
Venetoclax is an investigational drug being developed for the treatment of MCL. Ibrutinib is a drug approved for the treatment of MCL. Participants will receive venetoclax (increasing doses) and ibrutinib (fixed dose) for approximately 104 weeks, followed by ibrutinib alone. Adult participants with R/R MCL will be enrolled. Around 12 participants will be enrolled in Japan.
Participants will receive oral venetoclax tablet and oral ibrutinib capsule for 104 weeks. After 104 weeks, participants will receive ibrutinib once daily until their disease progresses, or they cannot tolerate the medication, or until they do not want to participate in the study.
There may be a higher treatment burden for participants in this study compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, bone marrow biopsies, checking for side effects, and completing questionnaires.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04477486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.