Mantle Cell Lymphoma (MCL)Phase 2NCT04477486
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
A Phase 2 study testing Ibrutinib and Venetoclax in people with Mantle Cell Lymphoma (MCL), run by AbbVie at 12 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mantle Cell Lymphoma (MCL)
- What is being tested?
- Ibrutinib and Venetoclax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 12 sitesJapan
- Study dates
- 23 Sep 2020to 28 May 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
National Cancer Center Hospital /ID# 221812
Chuo-ku, Tokyo, 104-0045
Kyushu University Hospital /ID# 223299
Fukuoka, Fukuoka, 812-8582
National Hospital Organization Mito Medical Center /ID# 224912
Ibaraki, Higashiibaraki, 311-3193
Ishikawa Prefectural Central Hospital /ID# 224896
Kanazawa, Ishikawa-ken, 920-8530
Saitama Medical Center /ID# 224910
Kawagoe-shi, Saitama, 350-8550
Kobe City Medical Center General Hospital /ID# 221744
Kobe, Hyōgo, 650-0047
NHO Nagoya Medical Center /ID# 221958
Nagoya, Aichi-ken, 460-0001
Aichi Cancer Center Hospital /ID# 221565
Nagoya, Aichi-ken, 464-8681
Duplicate_Okayama University Hospital /ID# 221623
Okayama, Okayama-ken, 700-8558
Hokkaido University Hospital /ID# 221662
Sapporo, Hokkaido, 060-8648
Tohoku University Hospital /ID# 221975
Sendai, Miyagi, 9808574
Yamagata University Hospital /ID# 221573
Yamagata, Yamagata, 990-9585
About this study
Official title: Phase 2 Study of the Efficacy and Safety of Venetoclax in Combination With Ibrutinib in Japanese Subjects With Relapsed/Refractory Mantle Cell Lymphoma
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.
Read more
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.
- Conditions
- Mantle Cell Lymphoma (MCL)
- Being tested
- Ibrutinib, Venetoclax
- Keywords
- MCL, Venetoclax, ABT-199, Ibrutinib, Imbruvica
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Also called Imbruvica
Capsule; Oral
VenetoclaxDrug
Also called ABT-199, Venclexta, GDC-0199, Venclyxto
Tablet; Oral
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib + Venetoclax | Experimental | Participants will receive Ibrutinib Dose A + Venetoclax in various doses until a target dose is reached, for up to 104 weeks, followed by Ibrutinib monotherapy. Receives: Drug: Ibrutinib; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Best Overall Response of Complete Response (CR), as Assessed by the Independent Review Committee (IRC)
Complete response rate (CRR), defined as the percentage of participants achieving a best overall response of complete response (CR) per the Revised Criteria for Response Assessment for Malignant Lymphoma following the Lugano classification (Cheson 2014), assessed by an Independent Review Committee (IRC).
Measured: Week 13
Secondary outcomes (9)
Percentage of Participants Achieving Best Overall Response of CR or PR, as Assessed by the IRC
Overall Response Rate (ORR), defined as the percentage of participants with a best overall response of CR or PR, per the Revised Criteria for Response Assessment for Malignant Lymphoma, assessed by an Independent Review Committee (IRC).
Measured: Median follow-up time of 48 months (range: 2.3 to 50.7)
Percentage of Participants Achieving Best Overall Response of CR as Assessed by the Investigator
Best overall response of CR is defined as the percentage of participants achieving a best overall response of CR for the venetoclax and ibrutinib combination, as assessed by the investigator per the Revised Criteria for Response Assessment for Malignant Lymphoma .
Measured: Median follow-up time of 48 months (range: 2.3 to 50.7)
Percentage of Participants Achieving Best Overall Response of CR or PR, as Assessed by the Investigator
Best overall response of CR or PR will be evaluated using ORR. The ORR is defined as the percentage of participants with a best overall response of CR or PR, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the investigator.
Measured: Median follow-up time of 48 months (range: 2.3 to 50.7)
Duration of Response (DOR) for Participants Who Achieved a Best Overall Response of CR or PR, as Assessed by the Investigator
DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the investigator.
Measured: Median follow-up time of 48 months (range: 2.3 to 50.7)
DOR for Participants Who Achieved a Best Overall Response of CR or PR, as Assessed by the IRC
DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the IRC.
Measured: Median follow-up time of 48 months (range: 2.3 to 50.7)
Undetectable Minimal Residual Disease (uMRD) in Peripheral Blood in Participants Who Achieve a Best Overall Response of CR as Assessed by the Investigator and the IRC
MRD rate is defined as the percentage of participants with uMRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the investigator.
Measured: Median follow-up time of 48 months (range: 2.3 to 50.7)
uMRD in Bone Marrow Participants Who Achieve a Best Overall Response of CR as Assessed by the Investigator and the IRC.
MRD rate is defined as the percentage of participants with uMRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by investigator and the IRC.
Measured: Median follow-up time of 48 months (range: 2.3 to 50.7)
Progression-Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug (venetoclax or ibrutinib) to the date of investigator-assessed disease progression, using the Revised Response Criteria for Response Assessment for Malignant Lymphoma, or death from any cause, whichever occurs first.
Measured: Median follow-up time of 48 months (range: 2.3 to 50.7)
Overall Survival (OS)
OS is defined as the time from the date of the first dose of the study drug (venetoclax or ibrutinib) to death from any cause.
Measured: Median follow-up time of 48 months (range: 2.3 to 50.7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start23 Sep 2020
- Primary completion9 Feb 2022
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mantle Cell Lymphoma (MCL)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477486
- Sponsor's protocol ID
- M20-075
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2020
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.