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New combo therapy for CLL shows promise in small japanese study

NCT ID NCT05105841

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed phase 2 study tested two drug combinations—venetoclax plus obinutuzumab or venetoclax plus ibrutinib—in 20 Japanese adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The goal was to see how well these combinations work and if they are safe. Participants received the drugs in 28-day cycles for up to 15 cycles, and doctors monitored their response and side effects.

What this could mean

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

Active substance
Venetoclax (Venclexta) combined with obinutuzumab (Gazyva) or ibrutinib (Imbruvica)
What this could lead to
If successful, this could show that these drug combinations are safe and effective for Japanese patients with CLL/SLL, potentially offering new treatment options.
What could go wrong
This is a small, early-phase study (20 participants) focused on Japanese patients, so results may not apply broadly. Side effects from the drug combinations are possible.

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

20 people

The number who actually took part.

Started

Nov 2021

Finished

Oct 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: * Adult male or female, at least ≥ 65 years old; or 20 to 64 years old and have at least 1 of the following: * Cumulative Illness Rating Scale (CIRS) score \> 6. * Creatinine clearance (CrCl) estimated \< 70 mL/min using Cockcroft-Gault equation. * Must have measurable nodal disease (by computed tomography \[CT\]), defined as at least one lymph node \> 1.5 cm in longest diameter. * Diagnosed Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that requires treatment according to the Modified 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. Exclusion Criteria: * Transformation of Chronic Lymphocytic Leukemia (CLL) to aggressive non-Hodgkin lymphoma (NHL; Richter's transformation or pro-lymphocytic leukemia). * Previous treatment history for CLL/SLL.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

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

Chronic lymphocytic leukemia (CLL) Small lymphocytic lymphoma (SLL)

Contacts and locations

Locations

  • Aichi Cancer Center Hospital /ID# 238797

    Nagoya, Aichi-ken, 464-8681, Japan

  • Duplicate_Chiba Cancer Center /ID# 238839

    Chiba, Chiba, 260-8717, Japan

  • Duplicate_Hokkaido University Hospital /ID# 238377

    Sapporo, Hokkaido, 060-8648, Japan

  • Duplicate_Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 233524

    Nagoya, Aichi-ken, 466-8650, Japan

  • Duplicate_Jichi Medical University Hospital /ID# 238434

    Shimotsuke-shi, Tochigi, 329-0498, Japan

  • Duplicate_NHO Nagoya Medical Center /ID# 233523

    Nagoya, Aichi-ken, 460-0001, Japan

  • Duplicate_Okayama University Hospital /ID# 238467

    Okayama, Okayama-ken, 700-8558, Japan

  • Duplicate_Osaka University Hospital /ID# 234037

    Suita-shi, Osaka, 565-0871, Japan

  • Duplicate_Shimane University Hospital /ID# 234076

    Izumo-shi, Shimane, 693-8501, Japan

  • Hyogo Prefectural Amagasaki General Medical Center /ID# 234082

    Amagasaki-shi, Hyōgo, 660-8550, Japan

  • Kindai University Hospital /ID# 234001

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Kyushu University Hospital /ID# 238437

    Fukuoka, Fukuoka, 812-8582, Japan

  • National Cancer Center Hospital /ID# 232449

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Hospital Organization Shikoku Cancer Center /ID# 234059

    Matsuyama, Ehime, 791-0280, Japan

  • Niigata University Medical & Dental Hospital /ID# 238324

    Niigata, Niigata, 951-8520, Japan

  • The Cancer Institute Hospital Of JFCR /ID# 232450

    Koto-ku, Tokyo, 135-8550, Japan

  • Tohoku University Hospital /ID# 238433

    Sendai, Miyagi, 9808574, Japan

  • Tokai University Hospital /ID# 238970

    Isehara, Kanagawa, 259-1193, Japan

  • University Hospital Kyoto Prefectural University of Medicine /ID# 239883

    Kyoto, Kyoto, 602-8566, Japan

  • Yamagata University Hospital /ID# 234032

    Yamagata, Yamagata, 990-9585, Japan

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