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

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

NCT ID: NCT05899621

Condition: Follicular Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Prednisone
Cyclophosphamide
Bendamustine Hydrochloride
Doxorubicin
Vincristine
Lenalidomide
Obinutuzumab

Conditions: Keywords:
obinutuzumab
Lymphoma

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: Obinutuzumab
Description: Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
Arm group label: GB
Arm group label: GCHOP
Arm group label: GR

Intervention type: Drug
Intervention name: Lenalidomide
Description: Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Arm group label: GR

Intervention type: Drug
Intervention name: Bendamustine
Description: Bendamustine IV infusion will be administered as per the schedule specified in the respective arm.
Arm group label: GB

Intervention type: Drug
Intervention name: Cyclophosphamide
Description: Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Arm group label: GCHOP

Intervention type: Drug
Intervention name: Doxorubicin
Description: Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Arm group label: GCHOP

Intervention type: Drug
Intervention name: Vincristine
Description: Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Arm group label: GCHOP

Intervention type: Drug
Intervention name: Prednisone
Description: Prednisone PO will be administered as per the schedule specified in the respective arm.
Arm group label: GCHOP

Summary: This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma

Detailed description: This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Criteria for eligibility:

Study pop:
patients age ≥18 years with grade 1 to 3a FL.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification - Treatment naive - Age ≥ 18 years - Indications for treatment confirmed - Must has measurable lesion in CT or PET-CT prior to treatment - Considered suitable for GR, GB or GCHOP regimens - Informed consented Exclusion Criteria: - Transformed follicular lymphoma or 3B follicular lymphoma; - HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive - Central nervous system or meninges involved - Any drug contraindication in the treatment plan - Patients judged by other researchers to be unsuitable for inclusion in the study

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Address:
City: Shanghai
Zip: 200025
Country: China

Status: Recruiting

Contact:
Last name: Weili Zhao, M.D. and Ph.D
Email: zhao.weili@yahoo.com

Start date: June 1, 2023

Completion date: June 30, 2027

Lead sponsor:
Agency: Ruijin Hospital
Agency class: Other

Source: Ruijin Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05899621