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Can a drug combo shrink Hard-to-Treat lymphoma tumors?

NCT ID NCT04477486

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This Phase 2 trial tests whether adding venetoclax to ibrutinib can improve complete responses in Japanese adults with mantle cell lymphoma that has returned or not responded to treatment. Participants take both oral drugs for about 104 weeks, then continue ibrutinib alone until the disease worsens or side effects become intolerable. The study measures how many people achieve a complete response, meaning no detectable cancer, and also tracks safety and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
venetoclax combined with ibrutinib
What this could lead to
If the combination works, it could offer a more effective treatment option for people with mantle cell lymphoma that has returned or stopped responding to prior therapy.
What could go wrong
This is a small, early-phase study with about 12 participants, so results may not apply broadly. The combination may cause side effects, and the added benefit over ibrutinib alone is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

13 people

The number who actually took part.

Started

Sep 2020

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

mantle cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mantle cell lymphoma (MCL)

Contacts and locations

Locations

  • Aichi Cancer Center Hospital /ID# 221565

    Nagoya, Aichi-ken, 464-8681, Japan

  • Duplicate_Okayama University Hospital /ID# 221623

    Okayama, Okayama-ken, 700-8558, Japan

  • Hokkaido University Hospital /ID# 221662

    Sapporo, Hokkaido, 060-8648, Japan

  • Ishikawa Prefectural Central Hospital /ID# 224896

    Kanazawa, Ishikawa-ken, 920-8530, Japan

  • Kobe City Medical Center General Hospital /ID# 221744

    Kobe, Hyōgo, 650-0047, Japan

  • Kyushu University Hospital /ID# 223299

    Fukuoka, Fukuoka, 812-8582, Japan

  • NHO Nagoya Medical Center /ID# 221958

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Cancer Center Hospital /ID# 221812

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Hospital Organization Mito Medical Center /ID# 224912

    Ibaraki, Higashiibaraki, 311-3193, Japan

  • Saitama Medical Center /ID# 224910

    Kawagoe-shi, Saitama, 350-8550, Japan

  • Tohoku University Hospital /ID# 221975

    Sendai, Miyagi, 9808574, Japan

  • Yamagata University Hospital /ID# 221573

    Yamagata, Yamagata, 990-9585, Japan

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