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New pill hopes to tame rare blood cancer in japanese patients

NCT ID NCT07387471

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 10, 2026 · Updated 6 times

Summary

This study tests a cancer pill called venetoclax in 14 Japanese adults with a rare blood cancer (Waldenström macroglobulinemia) that has come back or not responded to treatment. Participants take the drug by mouth daily, with doses slowly increased. The main goal is to see how many patients have a major reduction in their cancer. The study lasts about 28 months and involves regular check-ups and blood tests.

What this could mean

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

Active substance
Venetoclax (a targeted cancer pill)
What this could lead to
If successful, this could offer a new oral treatment option for Japanese patients with Waldenström macroglobulinemia that has stopped responding to prior therapy.
What could go wrong
This is a small, early-phase study (14 people) with no placebo comparison. The drug may not work as hoped, and side effects like low blood counts or infections 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

About 14 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

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

18 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: * Documented diagnosis of Waldenström macroglobulinemia(WM) /lymphoplasmacytic lymphoma (LPL) according to the 5th edition of the World Health Organization (WHO) classification and/or documented clinicopathological diagnosis of WM in accordance with the consensus panel of the second International Workshop on WM (IWWM). * At least one prior standard therapy for WM/LPL. * Measurable disease, defined as follows: * WM type LPL population: Immunoglobulin M (IgM) \>= 500 mg/dL per central laboratory (approximately 14 participants) * Non-IgM type LPL population or IgM \< 500 mg/dL: A measurable node having a longest diameter (LDi) greater than 1.5 cm, or a measurable extranodal disease having a LDi greater than 1.0 cm, according to contrast-enhanced computed tomography (CT) scan. (up to 2 participants) * Requires systemic anti-cancer treatment for WM/LPL, according to the investigator. * Eastern Cooperative Oncology Group Performance Status \< = 2 * Adequate organ and bone marrow function Exclusion Criteria: * History of prior exposure to venetoclax or BCL-2 targeted therapy. * Uncontrolled active systemic infection. * Known bleeding disorders (e.g., hemophilia).

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Conditions

The condition(s) this trial relates to.

Lymphoma, B-Cell, Marginal Zone lymphoplasmacytic lymphoma neoplasm Waldenstrom macroglobulinemia

As listed by the trial registrant

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

Lymphoplasmacytic lymphoma Waldenstrom macroglobulinemia

Contacts and locations

Locations

  • Chiba Cancer Center /ID# 279177

    Chiba, 260-0801, Japan

  • Gunma University Hospital /ID# 277576

    Maebashi, Gunma, 371-8511, Japan

  • Hiroshima University Hospital /ID# 279172

    Hiroshima, Hiroshima, 734-8551, Japan

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 279178

    Nagoya, Aichi-ken, 466-8650, Japan

  • Japanese Red Cross Medical Center /ID# 277577

    Shibuya-ku, Tokyo, 150-8935, Japan

  • Kindai University Hospital /ID# 277587

    Sakai-shi, Osaka, 590-0197, Japan

  • Kyushu University Hospital /ID# 277582

    Fukuoka, Fukuoka, 812-8582, Japan

  • NHO Mito Medical Center /ID# 279175

    Higashiibaraki-gun, Ibaraki, 311-3193, Japan

  • Nagano Red Cross Hospital /ID# 279774

    Nagano, 380-8582, Japan

  • Nagoya City University Hospital /ID# 277580

    Nagoya, Aichi-ken, 467-8602, Japan

  • National Cancer Center Hospital /ID# 279076

    Chuo-Ku, Tokyo, 104-0045, Japan

  • National Hospital Organization Disaster Medical Center /ID# 277741

    Tachikawa, Tokyo, 190-0014, Japan

  • The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 277579

    Koto-ku, Tokyo, 135-8550, Japan

  • The University of Tokyo Hospital /ID# 279174

    Bunkyo-ku, Tokyo, 113-8654, Japan

  • University Hospital Kyoto Prefectural University of Medicine /ID# 277584

    Kyoto, Kyoto, 602-8566, Japan

  • University of Fukui Hospital /ID# 279173

    Yoshida-gun, Fukui, 910-1104, Japan

  • University of Yamanashi Hospital /ID# 279179

    Chuo-shi, Yamanashi, 409-3898, Japan

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