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Experimental cocktail aims to tackle tough lymphoma

NCT ID NCT04049825

Disease control Sponsor: Otsuka Pharmaceutical Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tested an experimental drug called OPB-111077 combined with two standard chemotherapy drugs (bendamustine and rituximab) in 36 people whose diffuse large B-cell lymphoma had come back or stopped responding to treatment. The main goal was to check the safety and find the right dose, not to measure how well it works. The study is already completed.

What this could mean

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

Active substance
OPB-111077 (an experimental drug) combined with bendamustine and rituximab (standard chemotherapies)
What this could lead to
If successful, this could point toward a new combination treatment option for people with relapsed or refractory diffuse large B-cell lymphoma.
What could go wrong
This is a very early (Phase 1) trial with only 36 participants, focused on safety and dosing. It is not designed to prove effectiveness, and the combination may cause significant side effects or fail to work in larger studies.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

36 people

The number who actually took part.

Started

Nov 2019

Finished

Jan 2026

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 to 80 years

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: * Patients with a definite diagnosis of Diffuse large B-cell lymphoma(DLBCL) * Patients who have received at least initial standard treatment * Patients with measurable lesions (based on International Working Group \[IWG\] 2014 criteria) * Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 \<Only for dose-expansion stage\> * Patients who are pathologically diagnosed as CD20 positive lymphoma * Patients who have a history of being treated with 1 to 5 regimens of previous chemotherapy for the underlying disease Exclusion Criteria: * Patients who are candidates for autologous or allogeneic hematopoietic stem cell transplantation * Patients who were refractory to initial standard treatment * Patients who have a history of bendamustine administration and are intolerant to bendamustine * Patients with central nervous system (CNS) involvement of lymphoma or with a history of CNS involvement of lymphoma * Patients diagnosed with DLBCL transformed from low-grade B-cell non-Hodgkin's lymphoma (NHL) \<Only for dose-expansion stage\> \- Patients who have a history of rituximab administration and are intolerant to rituximab

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma Recurrence relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

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

Relapsed or refractory diffuse large B-cell lymphoma

Contacts and locations

Locations

  • Yamagata University Hospital

    Yamagata, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.