Using obinutuzumab with bendamustine to treat mature B-cell lymphoma

Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma: an Open-label, Multicenter Study

This study is testing if a two-year treatment with obinutuzumab can help adults with newly diagnosed mature B-cell lymphoma who have improved after their first treatment with obinutuzumab and bendamustine.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: otuzumab, chemotherapy, immunotherapy, radiation, prednisone, obinutuzumab
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06415708 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of a two-year maintenance therapy with obinutuzumab in patients aged 18 and older who have newly diagnosed mature B-cell lymphoma and have shown a partial response after initial treatment with obinutuzumab and bendamustine. The study is a single-center, single-arm trial that aims to improve patient outcomes by exploring the efficacy of this combination therapy across various lymphoma subtypes. Participants will receive obinutuzumab as a maintenance treatment following their initial therapy to assess its impact on prognosis.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed mature B-cell lymphoma who have achieved at least a partial response after initial treatment.

Not a fit: Patients with other types of lymphoma or those who do not meet the specific histological criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the prognosis and quality of life for patients with mature B-cell lymphoma.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating B-cell lymphomas, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients voluntarily participate in this study, sign informed consent and comply with the study trial protocol
2. Age ≥ 18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
4. FL (grade 1 - 3a), MZL, WM, HCL-v with histological documentation of CD20 positivity
5. Systemic therapy as assessed by the investigator based on tumor size and/or GELF criteria
6. Histological confirmation of MZL. For splenic marginal zone lymphoma (SMZL) for which splenic histological specimens cannot be obtained, it is required to meet the minimum diagnostic criteria for SMZL and rule out any other type of small B-cell lymphoma, that is, it is required to confirm the diagnosis of MZL. If the patient had gastric extranodal MZL with symptoms: H. pylori-negative primary lesion or re-lesion after local therapy (i.e., surgery or radiation therapy), the investigator judged whether treatment was required, and if H. pylori-positive, stable disease, progression, or recurrence after antibiotic treatment, the investigator judged whether treatment was required
7. Waldenström macroglobulinemia,lymphoplasmacytic lymphoma,WM/LPL(WM/LPL): meets the diagnostic criteria for WM/LPL and is indicated for treatment (meets at least one of the following conditions): symptomatic hyperviscosity; symptomatic peripheral neuropathy; amyloidosis; cold agglutinin disease; cryoglobulinemia; disease-related cytopenias (Hb \< 100 g/L, PLT \< 100 × 109/L); giant lymph nodes; those with systemic symptoms: persistent for two weeks/recurrent fever (above 38℃) and not caused by infection, or night sweats and/or weight loss \> 10% within 6 months; rapid disease progression, such as lymph node enlargement of more than 50% within 2 months, and/or absolute doubling time of peripheral blood lymphocytes \< 6 months, and/or rapid decrease in hemoglobin or platelets due to non-autoimmune causes
8. HCL-v: Meet the WHO diagnostic criteria (4th Edition, 2016), and treatment is indicated
9. At least one two-dimensional measurable lymph node lesion (maximum diameter \> 1.5 cm by CT scan or MRI), or at least one two-dimensional measurable extranodal lesion (maximum diameter \> 1.0 cm by CT scan or MRI)
10. Life expectancy ≥ 3 months
11. Adequate blood function (except for abnormalities considered by the investigator to be due to the underlying disease of lymphoma), defined as follows: hemoglobin ≥ 7 g/dL absolute neutrophil count ≥ 1.0 × 10\^9/L platelet count ≥ 50 × 10\^9/L
12. Normal laboratory values: creatinine clearance ≥ 30 mL/min AST or ALT ≤ 2.5 x upper limit of normal (ULN) Serum bilirubin ≤ 2 x ULN (≤ 3 x ULN for patients with Gilbert's syndrome) measured or estimated according to institutional standard methods
13. For men who are not surgically sterile: Agree to use barrier contraception during treatment and for at least 3 months after the last dose of otuzumab or bendamustine or as required by guidelines established by the institution, whichever is longer. In addition, male patients must agree to have their partner use an alternative method of contraception (e.g., oral contraceptive, intrauterine device, barrier method, or spermicide)
14. For women who are not surgically sterilized: agree to use two appropriate methods of contraception, such as oral contraceptives, intrauterine devices, or barrier methods, with spermicide for at least 28 days before starting study drug, during treatment, and for at least 12 months after the last dose of otuzumab or bendamustine, or for the time required by the guidelines established by the study institution (whichever is longer)

Exclusion Criteria:

1. Mature B-cell lymphoma previously treated with chemotherapy, immunotherapy, or radiation therapy
2. Evidence of aggressive NHL transformation
3. Known hypersensitivity to any study drug
4. Known sensitive to murine products
5. Central nervous system or meningeal involvement by lymphoma
6. Contraindications to the investigational drug included in the study treatment regimen
7. Positive test results for chronic hepatitis B infection (defined as positive HBsAg serology)
8. Hepatitis C positive (hepatitis C virus \[HCV\] antibody serology)
9. HIV or Human T-Lymphocytic Leukemia Virus 1 (HTLV1) positive
10. Evidence of any serious, uncontrolled co-morbidities that could affect compliance with the study protocol or interpretation of results, including but not limited to significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmias, or unstable angina), or significant pulmonary disease (including history of obstructive pulmonary disease or bronchospasm);
11. Infection caused by known active bacteria, viruses, fungi, or other microorganisms (except fungal infection of the nail bed), or any major infection requiring intravenous antibiotics or hospitalization (completion of the entire course of antibiotics, except for neoplastic fever) within 4 weeks prior to enrollment
12. Previous history of malignancy other than lymphoma, unless the subject has a disease-free survival of ≥ 5 years
13. Pregnant or lactating women.
14. Participated in other clinical trials using drug interventions during the trial or within 28 days prior to Cycle 1 Corticosteroids within 4 weeks of enrollment, unless administered at a dose equivalent to ≤ 30 mg/day prednisone (within 4 weeks)

16\. Past history of progressive multifocal leukoencephalopathy (PML) Vaccination with live vaccines within 28 days prior to start of treatment 18. History of solid organ transplantation 19. Presence of any serious disease or abnormality in the clinical laboratory test results that, in the opinion of the investigator, could make the patient unable to safely participate in and complete this study, or affect protocol compliance or interpretation of results

Where this trial is running

Tianjin, Tianjin Municipality

• Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Principal investigator: Shuhua Yi, Dr — Institute of Hematology & Blood Diseases Hospital, Chinese
• Study coordinator: Shuhua Yi, Dr

Conditions B Cell Lymphoma; Obinutuzumab; Bendamustine