Waldenström Macroglobulinemia (WM)Phase 1NCT07169565
Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia
A Phase 1 study testing Ibrutinib, Bendamustine and Rituximab in people with Waldenström Macroglobulinemia (WM), run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This is a two-part, non-randomized, open-label Phase I clinical study. The research consists of: 1. A 3+3 dose-escalation phase to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of the I+BR regimen in Waldenström Macroglobulinemia (WM) patients; 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Waldenström Macroglobulinemia (WM)
- What is being tested?
- Ibrutinib, Bendamustine and Rituximab
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2028
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient fully understands the study, voluntarily participates, and signs the Informed Consent Form (ICF).
- Patient of any gender, aged ≥18 years and ≤75 years.
- Patient must meet diagnostic criteria for Waldenström Macroglobulinemia (WM) and be MYD88 L265P mutation positive.
- 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.
- ECOG performance status score of 0-1.
- Patient has received ≥12 cycles of ibrutinib monotherapy, achieved a treatment response (but not Complete Response (CR) ), and is currently on a treatment plateau.
Show all 16Show fewer
- Patient has maintained good treatment tolerance (experienced no Grade ≥3 adverse reactions during ibrutinib therapy) and is still receiving ibrutinib.
- Patient has no prior treatment with Bendamustine combined with Rituximab (BR) regimen.
- 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).
- Patient has an estimated life expectancy ≥6 months.
Who cannot join
- 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.
- Clinical evidence of transformation to large cell lymphoma.
- Non-lymphoma related liver or kidney impairment:
- ALT >3 × ULN
- AST >3 × ULN
- Total bilirubin (TBIL) >2 × ULN
Show all 26Show fewer
- Serum creatinine clearance <30 mL/min.
- 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.
- Cardiac function or disease meeting any of the following:
- Long QTc syndrome or QTc interval >480 ms;
- Complete left bundle branch block, second- or third-degree atrioventricular block;
- Severe, uncontrolled arrhythmias requiring drug therapy;
- New York Heart Association (NYHA) classification ≥ Class III;
- Left ventricular ejection fraction (LVEF) <50%;
- 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.
- 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.
- Major surgery within 14 days prior to enrollment (excluding lymph node biopsy) or anticipated need for major surgery during the study.
- 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).
- Pregnant or lactating women, or women of childbearing potential not using contraception.
- Hypersensitivity to any of the study drugs or their components.
- 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).
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
- History of bleeding diathesis (e.g., hemophilia, von Willebrand disease).
- 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.
- Diagnosis of gastrointestinal ulcer by endoscopy within 3 months prior to the first dose of study drug.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase I Clinical Study of Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia
This is a two-part, non-randomized, open-label Phase I clinical study. The research consists of:
- A 3+3 dose-escalation phase to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of the I+BR regimen in Waldenström Macroglobulinemia (WM) patients;
- A dose-expansion phase to evaluate the safety, tolerability, and efficacy of the time-limited regimen at the MTD/RP2D.
Read more
Key Study Design Details:
Pre-enrollment \& Eligibility:
- Patients undergo efficacy and tolerability assessment before enrollment.
- Eligible patients receive I+BR therapy.
Treatment Regimen:
- Bendamustine: Tested at three dose levels (70 mg/m², 60 mg/m², and 50 mg/m²) based on prior IBR data in B-cell lymphomas. A 3+3 dose de-escalation design is employed.
- Fixed Doses:
- Ibrutinib: 420 mg/day
- Rituximab: 375 mg/m²
Part I (3+3 Dose Escalation):
- Start with 3 patients receiving bendamustine 70 mg/m².
- After 1 treatment cycle:
- Assess Dose-Limiting Toxicity (DLT) (DLT criteria defined separately).
- Patients without DLT proceed to 2 additional cycles of IBR.
- After 3 total cycles:
- Efficacy assessment is performed.
- Patients achieving minimal response (MR) or better (i.e., MR, PR, VGPR, CR) receive 1 cycle of BR, then cease treatment and enter follow-up.
- Patients failing to achieve ≥MR are withdrawn.
- Primary Objective: Evaluate safety and identify MTD.
Part II (Dose Expansion):
- Enroll 15 additional patients at MTD/RP2D.
- Objectives:
- Further assess safety and efficacy;
- Monitor IgM rebound within 2 months after completing therapy (3 cycles I+BR → 1 cycle BR);
- Explore correlations between biomarkers and clinical outcomes.
Terminology Notes:
- I+BR: Ibrutinib + Bendamustine/Rituximab
- DLT: Dose-Limiting Toxicity
- MTD: Maximum Tolerated Dose
- RP2D: Recommended Phase II Dose
- Efficacy thresholds: MR (Minimal Response), PR (Partial Response), VGPR (Very Good Partial Response), CR (Complete Response)
- Time-limited therapy: Fixed-duration treatment designed to avoid indefinite dosing.
- Conditions
- Waldenström Macroglobulinemia (WM)
- Being tested
- Ibrutinib, Bendamustine, Rituximab
- Keywords
- Waldenström Macroglobulinemia, ibrutinib, fixed dose
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Oral Bruton's tyrosine kinase (BTK) inhibitor administered at a fixed dose of 420 mg once daily. Capsules must be swallowed whole with water; do not open, break, or chew. If a dose is missed by ≤6 hours, take immediately; if >6 hours, skip the dose and resume normal schedule the next day. Avoid grapefruit and Seville oranges (moderate CYP3A inhibitors). Treatment duration: 3 cycles (28 days/cycle) or until disease progression/unacceptable toxicity. Dose reduction is mandated for specific toxicities: 420 mg → 280 mg → 140 mg → discontinuation (per protocol-specified criteria). Use with caution in hepatic impairment (Child-Pugh A: reduce to 80 mg/day; Child-Pugh B/C: contraindicated).
BendamustineDrug
Intravenous alkylating agent dosed via a 3+3 dose de-escalation design (70 mg/m² → 60 mg/m² → 50 mg/m²). Infused over 60-120 minutes on Days 1-2 of each 28-day cycle for 3 cycles. Starting dose: 70 mg/m² (Dose Level 1); dose reduction triggered by Dose-Limiting Toxicity (DLT) events per protocol. In the dose-expansion phase, all subjects receive the MTD/RP2D established in Part 1. Concomitant live vaccines are prohibited. Dose delays (≤4 weeks) and reductions are required for Grade ≥3 hematologic/non-hematologic toxicities.
RituximabDrug
Intravenous anti-CD20 monoclonal antibody administered at a fixed dose of 375 mg/m² on Day 0 of each 28-day cycle for 3 cycles. Initial infusion starts at 50 mg/hour; if tolerated, increase by 50 mg/hour every 30 minutes (maximum: 400 mg/hour). Subsequent infusions start at 100 mg/hour with the same escalation. Premedication with acetaminophen and an antihistamine is required prior to each infusion. Permanently discontinue for Grade 4 infusion-related reactions or severe/life-threatening toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib + BR Combination Therapy | Experimental | 1. A 3+3 dose-escalation phase to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of the I+BR regimen in Waldenström Macroglobulinemia (WM) patients;
2. A dose-expansion phase to evaluate the safety, tolerability, and efficacy of the time-limited regimen at the MTD/RP2D. Receives: Drug: Ibrutinib; Drug: Bendamustine; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Dose Escalation (Part 1) Incidence of Dose-Limiting Toxicities (DLTs)
Proportion of participants experiencing protocol-defined DLTs during Cycle 1 (28 days). DLTs include Grade ≥3 non-hematologic or specific hematologic toxicities (e.g., febrile neutropenia, Grade 4 thrombocytopenia >7 days) attributed to IBR regimen per NCI CTCAE v4.0 criteria (Section 2.4).
Measured: Cycle 1 (Days 1-28)
Phase 1: Dose Escalation (Part 1) Maximum Tolerated Dose (MTD) of Bendamustine
Highest dose level (70/60/50 mg/m²) at which ≤1 of 6 participants experience DLTs during Cycle 1, determined via 3+3 dose-escalation design (Section 2.1).
Measured: End of Dose Escalation Phase (approximately 6 months)
Phase 1: Dose Escalation (Part 1) Recommended Phase 2 Dose (RP2D)
Optimal dose of Bendamustine for expansion phase, derived from MTD evaluation integrated with safety/tolerability data (Section 2.1).
Measured: End of Dose Escalation Phase (approximately 6 months)
Phase 2: Dose Expansion (Part 2) Treatment-Emergent Adverse Events (TEAEs) at RP2D
Frequency and severity of TEAEs (Grade ≥3 per NCI CTCAE v4.0) attributed to IBR regimen at the RP2D. Includes hematologic, non-hematologic, and serious adverse events.
Measured: From first dose until 30 days after last dose (up to 5 months)
Phase 2: Dose Expansion (Part 2) Overall Response Rate (ORR) at RP2D
Proportion of participants achieving ≥Partial Response (PR) per Consensus Panel Criteria from the 8th International Workshop on Waldenström Macroglobulinemia (IWWM-8) after 3 cycles of IBR therapy.
Measured: At end of Cycle 3 (Day 84 ±3 days)
Secondary outcomes (4)
IgM rebound rate
Proportion of participants experiencing an IgM rebound, defined as a ≥25% increase in serum IgM levels from the end-of-treatment measurement, within 2 months after discontinuation of the time-limited therapy.
Measured: At 2 months after the last dose of study treatment
Duration of Response (DOR)
Time from the date of initial documented response (partial response or better) to the date of documented disease progression or death from any cause, whichever occurs first.
Measured: From the first documented response until disease progression/recurrence (assessed up to 24 months)
Progression-Free Survival (PFS)
Time from the first dose of study drug to the date of documented disease progression or death from any cause, whichever occurs first.
Measured: From first dose until disease progression or death (assessed up to 24 months)
Biomarker correlation with efficacy
Assessment of the association between specific biomarker levels (e.g., CXCR4 mutation status) and clinical efficacy outcomes (e.g., overall response rate).
Measured: Biomarker samples collected at baseline; efficacy assessed through study completion (approximately 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenström Macroglobulinemia (WM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169565
- Sponsor's protocol ID
- IIT2022026
- Status last verified
- Sep 2025
- First submitted
- 31 Jul 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected in this study are sensitive patient information. Due to privacy restrictions outlined in the informed consent form and institutional policies, the individual participant data will not be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia
- ClinicalTrials.gov ID
- NCT07169565
- Acronym / sponsor ID
- IIT2022026
- Conditions
- Waldenström Macroglobulinemia (WM)
- Keywords
- Waldenström Macroglobulinemia, ibrutinib, fixed dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-part, non-randomized, open-label Phase I clinical study. The research consists of:
- A 3+3 dose-escalation phase to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of the I+BR regimen in Waldenström Macroglobulinemia (WM) patients;
- A dose-expansion phase to evaluate the safety, tolerability, and efficacy of the time-limited regimen at the MTD/RP2D.
Key Study Design Details:
Pre-enrollment \& Eligibility:
- Patients undergo efficacy and tolerability assessment before enrollment.
- Eligible patients receive I+BR therapy.
Treatment Regimen:
- Bendamustine: Tested at three dose levels (70 mg/m², 60 mg/m², and 50 mg/m²) based on prior IBR data in B-cell lymphomas. A 3+3 dose de-escalation design is employed.
- Fixed Doses:
- Ibrutinib: 420 mg/day
- Rituximab: 375 mg/m²
Part I (3+3 Dose Escalation):
- Start with 3 patients receiving bendamustine 70 mg/m².
- After 1 treatment cycle:
- Assess Dose-Limiting Toxicity (DLT) (DLT criteria defined separately).
- Patients without DLT proceed to 2 additional cycles of IBR.
- After 3 total cycles:
- Efficacy assessment is performed.
- Patients achieving minimal response (MR) or better (i.e., MR, PR, VGPR, CR) receive 1 cycle of BR, then cease treatment and enter follow-up.
- Patients failing to achieve ≥MR are withdrawn.
- Primary Objective: Evaluate safety and identify MTD.
Part II (Dose Expansion):
- Enroll 15 additional patients at MTD/RP2D.
- Objectives:
- Further assess safety and efficacy;
- Monitor IgM rebound within 2 months after completing therapy (3 cycles I+BR → 1 cycle BR);
- Explore correlations between biomarkers and clinical outcomes.
Terminology Notes:
- I+BR: Ibrutinib + Bendamustine/Rituximab
- DLT: Dose-Limiting Toxicity
- MTD: Maximum Tolerated Dose
- RP2D: Recommended Phase II Dose
- Efficacy thresholds: MR (Minimal Response), PR (Partial Response), VGPR (Very Good Partial Response), CR (Complete Response)
- Time-limited therapy: Fixed-duration treatment designed to avoid indefinite dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib + BR Combination Therapy | Experimental | Drug: Ibrutinib, Drug: Bendamustine, Drug: Rituximab1. A 3+3 dose-escalation phase to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of the I+BR regimen in Waldenström Macroglobulinemia (WM) patients; 2. A dose-expansion phase to evaluate the safety, tolerability, and efficacy of the time-limited regimen at the MTD/RP2D. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient fully understands the study, voluntarily participates, and signs the Informed Consent Form (ICF).
- Patient of any gender, aged ≥18 years and ≤75 years.
- Patient must meet diagnostic criteria for Waldenström Macroglobulinemia (WM) and be MYD88 L265P mutation positive.
- 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.
- ECOG performance status score of 0-1.
Key exclusion criteria (26 listed)
- 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.
- Clinical evidence of transformation to large cell lymphoma.
- Non-lymphoma related liver or kidney impairment:
- 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.
- Cardiac function or disease meeting any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbrutinibOral Bruton's tyrosine kinase (BTK) inhibitor administered at a fixed dose of 420 mg once daily. Capsules must be swallowed whole with water; do not open, break, or chew. If a dose is missed by ≤6 hours, take immediately; if >6 hours, skip the dose and resume normal schedule the next day. Avoid grapefruit and Seville oranges (moderate CYP3A inhibitors). Treatment duration: 3 cycles (28 days/cycle) or until disease progression/unacceptable toxicity. Dose reduction is mandated for specific toxicities: 420 mg → 280 mg → 140 mg → discontinuation (per protocol-specified criteria). Use with caution in hepatic impairment (Child-Pugh A: reduce to 80 mg/day; Child-Pugh B/C: contraindicated). | Drug | Ibrutinib + BR Combination Therapy |
| BendamustineIntravenous alkylating agent dosed via a 3+3 dose de-escalation design (70 mg/m² → 60 mg/m² → 50 mg/m²). Infused over 60-120 minutes on Days 1-2 of each 28-day cycle for 3 cycles. Starting dose: 70 mg/m² (Dose Level 1); dose reduction triggered by Dose-Limiting Toxicity (DLT) events per protocol. In the dose-expansion phase, all subjects receive the MTD/RP2D established in Part 1. Concomitant live vaccines are prohibited. Dose delays (≤4 weeks) and reductions are required for Grade ≥3 hematologic/non-hematologic toxicities. | Drug | Ibrutinib + BR Combination Therapy |
| RituximabIntravenous anti-CD20 monoclonal antibody administered at a fixed dose of 375 mg/m² on Day 0 of each 28-day cycle for 3 cycles. Initial infusion starts at 50 mg/hour; if tolerated, increase by 50 mg/hour every 30 minutes (maximum: 400 mg/hour). Subsequent infusions start at 100 mg/hour with the same escalation. Premedication with acetaminophen and an antihistamine is required prior to each infusion. Permanently discontinue for Grade 4 infusion-related reactions or severe/life-threatening toxicity. | Drug | Ibrutinib + BR Combination Therapy |
Primary outcome
Phase 1: Dose Escalation (Part 1) Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 (Days 1-28)
Proportion of participants experiencing protocol-defined DLTs during Cycle 1 (28 days). DLTs include Grade ≥3 non-hematologic or specific hematologic toxicities (e.g., febrile neutropenia, Grade 4 thrombocytopenia >7 days) attributed to IBR regimen per NCI CTCAE v4.0 criteria (Section 2.4).
Phase 1: Dose Escalation (Part 1) Maximum Tolerated Dose (MTD) of Bendamustine
Time frame: End of Dose Escalation Phase (approximately 6 months)
Highest dose level (70/60/50 mg/m²) at which ≤1 of 6 participants experience DLTs during Cycle 1, determined via 3+3 dose-escalation design (Section 2.1).
Phase 1: Dose Escalation (Part 1) Recommended Phase 2 Dose (RP2D)
Time frame: End of Dose Escalation Phase (approximately 6 months)
Optimal dose of Bendamustine for expansion phase, derived from MTD evaluation integrated with safety/tolerability data (Section 2.1).
Phase 2: Dose Expansion (Part 2) Treatment-Emergent Adverse Events (TEAEs) at RP2D
Time frame: From first dose until 30 days after last dose (up to 5 months)
Frequency and severity of TEAEs (Grade ≥3 per NCI CTCAE v4.0) attributed to IBR regimen at the RP2D. Includes hematologic, non-hematologic, and serious adverse events.
Phase 2: Dose Expansion (Part 2) Overall Response Rate (ORR) at RP2D
Time frame: At end of Cycle 3 (Day 84 ±3 days)
Proportion of participants achieving ≥Partial Response (PR) per Consensus Panel Criteria from the 8th International Workshop on Waldenström Macroglobulinemia (IWWM-8) after 3 cycles of IBR therapy.
4 secondary outcomes
IgM rebound rate
Time frame: At 2 months after the last dose of study treatment
Duration of Response (DOR)
Time frame: From the first documented response until disease progression/recurrence (assessed up to 24 months)
Progression-Free Survival (PFS)
Time frame: From first dose until disease progression or death (assessed up to 24 months)
Biomarker correlation with efficacy
Time frame: Biomarker samples collected at baseline; efficacy assessed through study completion (approximately 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No. The data collected in this study are sensitive patient information. Due to privacy restrictions outlined in the informed consent form and institutional policies, the individual participant data will not be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibrutinib, Bendamustine and Rituximab in people with Waldenström Macroglobulinemia (WM), run by Institute of Hematology & Blood Diseases Hospital, China.
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 16 inclusion and 26 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: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Shuhua Yi (86-15900265415, yishuhua@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Dose Escalation (Part 1) Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1 (Days 1-28)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.