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AzTrials

Waldenstrom MacroglobulinemiaPhase 2NCT07387471

Study to Assess Change in Disease Activity of Oral Venetoclax in Adult Participants With Recurring Relapsed or Refractory (R/R) Waldenström Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)

A Phase 2 study testing Venetoclax in people with Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma, run by AbbVie at 17 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Lymphoplasmacytic Lymphoma (LPL) is a rare type of low-grade B-cell lymphoma. The purpose of this study is to assess the change in disease activity of adult participants with relapsed or refractory Waldenström macroglobulinemia(WM)/LPL receiving venetoclax. Venetoclax is being investigated in the treatment of WM/LPL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Venetoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
17 sitesJapan
Study dates
17 Mar 2026to Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • History of prior exposure to venetoclax or BCL-2 targeted therapy.
  • Uncontrolled active systemic infection.
  • Known bleeding disorders (e.g., hemophilia).

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Japan17 sites

  • The University of Tokyo Hospital /ID# 279174

    Bunkyo-ku, Tokyo, 113-8654

  • Chiba Cancer Center /ID# 279177

    Chiba, 260-0801

  • National Cancer Center Hospital /ID# 279076

    Chuo-Ku, Tokyo, 104-0045

  • University of Yamanashi Hospital /ID# 279179

    Chuo-shi, Yamanashi, 409-3898

  • Kyushu University Hospital /ID# 277582

    Fukuoka, Fukuoka, 812-8582

  • NHO Mito Medical Center /ID# 279175

    Higashiibaraki-gun, Ibaraki, 311-3193

  • Hiroshima University Hospital /ID# 279172

    Hiroshima, Hiroshima, 734-8551

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

    Koto-ku, Tokyo, 135-8550

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

    Kyoto, Kyoto, 602-8566

  • Gunma University Hospital /ID# 277576

    Maebashi, Gunma, 371-8511

  • Nagano Red Cross Hospital /ID# 279774

    Nagano, 380-8582

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

    Nagoya, Aichi-ken, 466-8650

  • Nagoya City University Hospital /ID# 277580

    Nagoya, Aichi-ken, 467-8602

  • Kindai University Hospital /ID# 277587

    Sakai-shi, Osaka, 590-0197

  • Japanese Red Cross Medical Center /ID# 277577

    Shibuya-ku, Tokyo, 150-8935

  • National Hospital Organization Disaster Medical Center /ID# 277741

    Tachikawa, Tokyo, 190-0014

  • University of Fukui Hospital /ID# 279173

    Yoshida-gun, Fukui, 910-1104

Other trials in Japan

About this study

Official title: A Phase 2 Study of Venetoclax Monotherapy in Japanese Subjects With Relapsed or Refractory Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma

Lymphoplasmacytic Lymphoma (LPL) is a rare type of low-grade B-cell lymphoma. The purpose of this study is to assess the change in disease activity of adult participants with relapsed or refractory Waldenström macroglobulinemia(WM)/LPL receiving venetoclax.

Venetoclax is being investigated in the treatment of WM/LPL. Participants will receive oral venetoclax at doses ramping up to the target dose, as part of treatment. Approximately 14 adult participants with WM/LPL will be enrolled in the study at approximately 20 sites in Japan.

Read more

Participants will receive oral venetoclax at doses ramping up to the target dose. The total study duration is approximately 28 months.

There may be higher treatment burden for participants in this trial 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, and checking for side effects.

Being tested
Venetoclax
Keywords
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma, Venetoclax, Venclexta, Cancer
Medical subject headings
Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07387471
Study groupRoleWhat they receive
Venetoclax MonotherapyExperimentalParticipants will receive venetoclax at doses ramping up to the target dose, as part of the approximately 28 month study duration.
Receives: Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Major Response

    Major response is defined as participants with a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR) per independent review committee (IRC) assessment according to International Workshop on Waldenstrom macroglobulinemia (WM) (IWWM)-11 criteria in participants with Immunoglobulin M (IgM) >= 500 mg/dL at screening.

    Measured: Up to Approximately 28 Months

  2. Number of Participants with Major Response in participants with IgM >= 500 mg/dL

    Major response is defined as participants with a best overall response of CR, VGPR or PR per IRC assessment according to IWWM-11.

    Measured: Up to Approximately 28 Months

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    PFS is defined as time from first study treatment to a documented disease progression (PD) according to IWWM-11 criteria, determined by investigator or death from any cause, whichever occurs first.

    Measured: Up to Approximately 28 Months

  2. Overall Survival (OS)

    OS is defined as time from first study treatment to death due to any cause.

    Measured: Up to Approximately 28 Months

  3. Overall Response (OR)

    For participants with IgM >= 500 mg/dL at screening, overall response is defined as participants with a best overall response of CR, VGPR, PR or minor response (MR) per investigator assessment according to IWWM-11 criteria. For participants with IgM < 500 mg/dL at screening, overall response is defined as participants with the best overall response of CR or PR per investigator assessment according to Revised Response Criteria for Malignant Lymphoma.

    Measured: Up to Approximately 28 Months

  4. Duration of Response (DOR)

    For participants with IgM >= 500 mg/dL at screening, DOR is defined as time from the initial response of CR, VGPR or PR per investigator review according to IWWM-11 criteria to PD or death of any cause, whichever occurs first. For participants with IgM < 500 mg/dL at screening, DOR is defined as time from the initial response of CR or PR per investigator review according to Revised Response Criteria for Malignant Lymphoma to PD or death of any cause, whichever occurs first. DOR will be summarized for the participants achieving overall response.

    Measured: Up to Approximately 28 Months

  5. Time to Next Treatment (TTNT)

    TTNT is defined as time from first study treatment to the starting date of new anti-cancer therapy.

    Measured: Up to Approximately 28 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start17 Mar 2026
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

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
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07387471
Sponsor's protocol ID
M25-558
Status last verified
Sep 2026
First submitted
28 Jan 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
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 Venetoclax in people with Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma, run by AbbVie at 17 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 8 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

This study is still under way. Results are not available in the source record yet.

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?

Number of Participants with Major Response (time frame: Up to Approximately 28 Months). The study lists 2 primary outcomes in all. 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 NCT07387471.

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 9 Sep 2026.

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