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B Cell LymphomaPhase 2NCT06415708

Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma

A Phase 2 study testing Obinutuzumab Combined With Bendamustine in people with B Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B Cell Lymphoma
What is being tested?
Obinutuzumab Combined With Bendamustine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteChina
Study dates
30 Nov 2023to 30 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients voluntarily participate in this study, sign informed consent and comply with the study trial protocol
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • FL (grade 1 - 3a), MZL, WM, HCL-v with histological documentation of CD20 positivity
  • Systemic therapy as assessed by the investigator based on tumor size and/or GELF criteria
  • 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
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  • 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
  • HCL-v: Meet the WHO diagnostic criteria (4th Edition, 2016), and treatment is indicated
  • 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)
  • Life expectancy ≥ 3 months
  • 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
  • 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
  • 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)
  • 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)

Who cannot join

  • Mature B-cell lymphoma previously treated with chemotherapy, immunotherapy, or radiation therapy
  • Evidence of aggressive NHL transformation
  • Known hypersensitivity to any study drug
  • Known sensitive to murine products
  • Central nervous system or meningeal involvement by lymphoma
  • Contraindications to the investigational drug included in the study treatment regimen
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  • Positive test results for chronic hepatitis B infection (defined as positive HBsAg serology)
  • Hepatitis C positive (hepatitis C virus [HCV] antibody serology)
  • HIV or Human T-Lymphocytic Leukemia Virus 1 (HTLV1) positive
  • 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);
  • 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
  • Previous history of malignancy other than lymphoma, unless the subject has a disease-free survival of ≥ 5 years
  • Pregnant or lactating women.
  • 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

Trial locations and contacts

1 site in 1 country.

Shuhua Yi, Dr contact

86-22-23909106

yishuhua@ihcams.ac.cn

Lugui Qiu, Dr contact

86-22-23909172

qiulg@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

    Yuting Yan

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Conditions
B Cell Lymphoma
Being tested
Obinutuzumab Combined With Bendamustine
Keywords
Obinutuzumab, Bendamustine
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Obinutuzumab Combined With BendamustineDrug

    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.

Study groups in NCT06415708
Study groupRoleWhat they receive
Obinutuzumab Combined With BendamustineExperimentalNot described
Receives: Drug: Obinutuzumab Combined With Bendamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Remission Rate(ORR)

    Disease response evaluation after 6 cycles will be used to determine the overall remission rate

    Measured: 24 weeks

Secondary outcomes (4)

  1. Progression Free Survival

    Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date.

    Measured: up to 4.5 years

  2. Event-Free Survival

    Event-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause.

    Measured: up to 4.5 years

  3. Complete Response Rate

    Disease response evaluation after 6 cycles will be used to determine the overall remission rate

    Measured: 24 weeks

  4. Overall survival

    Overall survival will be measured from the date of inclusion to the date of death from any cause.

    Alive patients will be censored at their last date known to be alive

    Measured: up to 4.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start30 Nov 2023
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06415708
Sponsor's protocol ID
BDHBcell2023
Status last verified
Jan 2024
First submitted
4 Mar 2024
Last updated
16 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obinutuzumab Combined With Bendamustine in people with B Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in 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 14 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shuhua Yi, Dr (86-22-23909106, yishuhua@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Remission Rate(ORR) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06415708.

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 16 May 2024.

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