New combo aims to shorten treatment for rare blood cancer
NCT ID NCT07169565
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tests a three-drug combination (ibrutinib, bendamustine, and rituximab) given for a fixed duration in people with Waldenström macroglobulinemia, a rare blood cancer. The study has two parts: first, finding the safest dose of bendamustine, and then testing that dose in more patients to check safety and early signs of effectiveness. Only 21 participants will be enrolled, and the goal is to see if a time-limited approach can control the disease without requiring lifelong medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ibrutinib, bendamustine, and rituximab
- What this could lead to
- If successful, this could lead to a fixed-duration treatment option for Waldenström macroglobulinemia, potentially reducing the need for lifelong therapy.
- What could go wrong
- This is a very early Phase 1 trial with only 21 participants. The main goal is safety and dose-finding, not proof of effectiveness. Side effects from the drug combination could be significant.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 21 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 1. Patient fully understands the study, voluntarily participates, and signs the Informed Consent Form (ICF). 2. Patient of any gender, aged ≥18 years and ≤75 years. 3. Patient must meet diagnostic criteria for Waldenström Macroglobulinemia (WM) and be MYD88 L265P mutation positive. 4. Patient has documented baseline IgM levels and disease assessment parameters (including liver, spleen, lymph nodes; if extramedullary lesions exist, include assessment of other extramedullary sites) prior to ibrutinib use, to facilitate subsequent efficacy evaluation. 5. ECOG performance status score of 0-1. 6. Patient has received ≥12 cycles of ibrutinib monotherapy, achieved a treatment response (but not Complete Response (CR) ), and is currently on a treatment plateau. 7. Patient has maintained good treatment tolerance (experienced no Grade ≥3 adverse reactions during ibrutinib therapy) and is still receiving ibrutinib. 8. Patient has no prior treatment with Bendamustine combined with Rituximab (BR) regimen. 9. Laboratory values: * Neutrophils ≥1.0 × 10⁹/L * Platelets ≥50 × 10⁹/L * Hemoglobin ≥70 g/L * Total bilirubin ≤2 × Upper Limit of Normal (ULN) * Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) ≤3 × ULN * Creatinine clearance (CrCl) ≥30 mL/min (calculated by Cockcroft-Gault formula). 10. Patient has an estimated life expectancy ≥6 months. Exclusion Criteria 1. Diagnosis or treatment for a malignancy other than B-cell Non-Hodgkin Lymphoma (B-NHL) within the past year (including active Central Nervous System lymphoma). Received other anti-tumor therapies (including chemotherapy, targeted therapy, hormonal therapy, anti-tumor Chinese herbs with activity) within 4 weeks prior to study drug administration (excluding ibrutinib) or participated in other clinical trials receiving investigational drugs. 2. Clinical evidence of transformation to large cell lymphoma. 3. Non-lymphoma related liver or kidney impairment: * ALT \>3 × ULN * AST \>3 × ULN * Total bilirubin (TBIL) \>2 × ULN * Serum creatinine clearance \<30 mL/min. 4. Other severe medical conditions that could interfere with the study (e.g., uncontrolled diabetes, gastric ulcer, other severe cardiopulmonary diseases), as determined by the investigator. 5. Cardiac function or disease meeting any of the following: 1. Long QTc syndrome or QTc interval \>480 ms; 2. Complete left bundle branch block, second- or third-degree atrioventricular block; 3. Severe, uncontrolled arrhythmias requiring drug therapy; 4. New York Heart Association (NYHA) classification ≥ Class III; 5. Left ventricular ejection fraction (LVEF) \<50%; 6. History within 6 months prior to enrollment: myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmia requiring treatment; history of clinically significant pericardial disease; or ECG evidence of acute ischemia or active conduction system abnormalities. 6. Known history of Human Immunodeficiency Virus (HIV) infection, or active Hepatitis B Virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics. Note: Active HBV infection is defined as meeting ALL THREE criteria: a. HBV DNA quantification ≥2000 IU/mL; b. ALT ≥2 × ULN; c. Hepatitis not attributable to other causes (e.g., disease itself, drugs). Patients initially diagnosed with active HBV infection who convert to inactive HBV status after anti-HBV therapy may be enrolled provided they receive adequate anti-HBV prophylaxis. 7. Major surgery within 14 days prior to enrollment (excluding lymph node biopsy) or anticipated need for major surgery during the study. 8. History or current diagnosis of another malignancy (except adequately controlled non-melanoma skin basal cell carcinoma, carcinoma in situ of the breast/cervix, and other malignancies effectively controlled without treatment for the past five years). 9. Pregnant or lactating women, or women of childbearing potential not using contraception. 10. Hypersensitivity to any of the study drugs or their components. 11. Malabsorption syndrome, disease significantly affecting gastrointestinal function, gastrectomy, extensive small bowel resection potentially affecting absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restriction/bariatric surgery (e.g., gastric bypass). 12. History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug. 13. History of bleeding diathesis (e.g., hemophilia, von Willebrand disease). 14. Requirement for or ongoing anticoagulation therapy with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days prior to the first dose of study drug. 15. Diagnosis of gastrointestinal ulcer by endoscopy within 3 months prior to the first dose of study drug.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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