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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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.
Show all 10Show fewer
  • 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

Other trials in Japan

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.

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 groups in NCT04477486
Study groupRoleWhat they receive
Ibrutinib + VenetoclaxExperimentalParticipants 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.

  1. 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)

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  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)

  8. 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)

  9. 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.

  1. First posted20 Jul 2020
  2. Study start23 Sep 2020
  3. Primary completion9 Feb 2022
  4. Study completion28 May 2025

Resources

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)
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
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibrutinib and Venetoclax in people with Mantle Cell Lymphoma (MCL), run by AbbVie at 12 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Best Overall Response of Complete Response (CR), as Assessed by the Independent Review Committee (IRC) (time frame: Week 13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04477486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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