Actively Recruiting

Age: 18Years +
All Genders
ID05899621

A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma

Led by Ruijin Hospital · Updated on 2023-06-12

332

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of obinutuzumab-based therapy in patients with previously untreated follicular lymphoma. This observational real-world study collects data from actual clinical practice, including patient demographics, tumor details, lab tests, past treatments, side effects, treatment responses, and possible factors that affect prognosis. The study is sponsored by Ruijin Hospital. Participants receive one of three treatment regimens involving obinutuzumab given by intravenous infusion, combined with either lenalidomide, bendamustine, or a combination of prednisone, cyclophosphamide, vincristine, and doxorubicin. Treatments include an induction phase of six 21-day cycles followed by maintenance therapy with obinutuzumab every three months for two years, and lenalidomide or no additional drugs depending on the regimen. During the study, participants undergo various assessments including imaging scans to measure tumor response, lab tests, and monitoring of side effects. Researchers evaluate the objective response rate six weeks after the last induction dose, along with complete response rate, progression-free survival, and duration of response over up to two years. The study tracks patient outcomes and safety throughout the treatment and follow-up periods, which extend until mid-2027.

CONDITIONS

Brief Title

A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
  • Treatment naive (no prior treatment for follicular lymphoma)
  • Age 18 years or older
  • Confirmed indications for treatment
  • Measurable lesion present in CT or PET-CT prior to treatment
  • Considered suitable for GR, GB, or GCHOP regimens
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Transformed follicular lymphoma or grade 3B follicular lymphoma
  • Positive for HBsAg and/or HBcAb with HBV DNA, positive for HCV antibody with HCV-RNA, or HIV positive
  • Involvement of central nervous system or meninges
  • Any drug contraindication to the planned treatment
  • Judged unsuitable for inclusion by other researchers

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Induction: six 21-day cycles; Maintenance: every 3 months for 2 years

Participants receive obinutuzumab-based therapy in one of three regimens (GR, GB, or GCHOP). Treatment includes induction cycles followed by maintenance therapy. Induction involves multiple intravenous infusions and oral medications over six 21-day cycles. Maintenance involves obinutuzumab infusions every 3 months for 2 years, with some regimens including additional oral medication cycles.

Multiple visits during induction (approximately 6 cycles) and maintenance visits every 3 months for 2 years

Follow-up

Duration - Up to approximately 2 years

Participants are monitored for efficacy and safety outcomes up to approximately 2 years after baseline, including progression-free survival and duration of response.

Periodic visits during follow-up up to 2 years

Trial Site Locations

Total: 1 location

1

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

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Research Team

W

Weili Zhao, +862164370045

P

Pengpeng Xu, PhD,MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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