Trial Title:
Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma
NCT ID:
NCT06415708
Condition:
B Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Bendamustine Hydrochloride
Obinutuzumab
Conditions: Keywords:
Obinutuzumab
Bendamustine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Obinutuzumab Combined With Bendamustine
Description:
The treatment is divided into two phases: induction therapy and maintenance therapy
Induction therapy: 6 cycles of obinutuzumab (1000 mg, IV) on Days 1, 8, and 15 of Cycle 1
and on Day 1 of Cycles 2-6 (28 days/cycle). Bendamustine (90 mg/m2, IV) on Days 1 and 2
of Cycles 1-6.
Maintenance therapy: Patients who achieved at least a partial response after 6 months of
induction therapy were eligible to enter the maintenance phase, during which obinutuzumab
(1000 mg, IV) was administered every 2 months for 2 years.
Arm group label:
Obinutuzumab Combined With Bendamustine
Summary:
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.
Detailed description:
This study will explore whether induction therapy with obinutuzumab in combination with
bendamustine followed by maintenance therapy with obinutuzumab in treatment-naïve
patients with mature B-cell lymphoma will improve the prognosis of patients with this
type of indolent mature B-cell lymphoma and the efficacy and safety of this regimen in
different lymphoma subtypes.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuting Yan
Start date:
November 30, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06415708
