Actively Recruiting
Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-05-16
134
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-center, single-arm clinical study to evaluate the efficacy and safety of maintenance therapy with obinutuzumab for 2 years in patients ≥ 18 years of age with newly diagnosed mature B-cell lymphoma (including follicular lymphoma\[FL\], marginal zone cell lymphoma\[MZL\] , waldenström macroglobulinemia\[WM\], hairy-cell leukemia variant\[HCL-v\]) who achieved ≥ PR after 6 cycles of obinutuzumab in combination with bendamustine.
CONDITIONS
Official Title
Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily agree to participate, sign informed consent, and follow the study protocol
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Diagnosis of follicular lymphoma (grade 1-3a), marginal zone lymphoma, Waldenström macroglobulinemia, or hairy-cell leukemia variant confirmed by CD20 positivity
- Systemic therapy needed based on tumor size or GELF criteria
- Histological confirmation of marginal zone lymphoma; for splenic marginal zone lymphoma, diagnosis confirmed by established criteria
- Waldenström macroglobulinemia or lymphoplasmacytic lymphoma meeting diagnostic criteria and requiring treatment
- Hairy-cell leukemia variant meeting WHO diagnostic criteria and requiring treatment
- At least one measurable lymph node lesion over 1.5 cm or extranodal lesion over 1.0 cm by CT or MRI
- Life expectancy of 3 months or more
- Adequate blood function: hemoglobin ≥ 7 g/dL, neutrophils ≥ 1.0 x 10^9/L, platelets ≥ 50 x 10^9/L
- Normal lab values: creatinine clearance ≥ 30 mL/min, AST/ALT ≤ 2.5 times upper normal limit, bilirubin ≤ 2 times upper normal limit (or ≤ 3 times for Gilbert's syndrome)
- Men not surgically sterile agree to use barrier contraception during treatment and for 3 months after last dose; female partners also use alternative contraception
- Women not surgically sterile agree to use two contraception methods starting 28 days before treatment, during, and for 12 months after last dose
You will not qualify if you...
- Previous treatment of mature B-cell lymphoma with chemotherapy, immunotherapy, or radiation
- Evidence of aggressive non-Hodgkin lymphoma transformation
- Known allergy to study drugs or sensitivity to murine products
- Central nervous system or meningeal lymphoma involvement
- Contraindications to study drugs
- Positive chronic hepatitis B infection
- Positive hepatitis C infection
- Positive HIV or HTLV1 infection
- Serious uncontrolled medical conditions affecting study compliance or safety, including severe heart or lung disease
- Active infections requiring intravenous antibiotics or hospitalization within 4 weeks before enrollment
- History of other malignancies unless disease-free for 5 years
- Pregnant or breastfeeding women
- Participation in other drug clinical trials within 28 days prior to study start
- High dose corticosteroids within 4 weeks before enrollment unless ≤ 30 mg/day prednisone equivalent
- History of progressive multifocal leukoencephalopathy
- Live vaccine within 28 days before treatment start
- History of solid organ transplantation
- Any serious disease or lab abnormality judged by investigator to prevent safe participation or affect results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
S
Shuhua Yi, Dr
CONTACT
L
Lugui Qiu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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