Health TrialsbyHealthPanel

Obinutuzumab in Chinese Real-world Patients With iNHL

ConditionLymphomas Non-Hodgkin's B-Cell
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAffiliated Hospital of Nantong University

About this trial

This study aims to assess the clinical efficacy and safety of obinutuzumab in Chinese patients with indolent non-Hodgkin B-cell Lymphoma (predominantly Follicular lymphoma and Marginal zone lymphoma) in a real-world setting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: Age ≥ 18 years at the start of treatment;

Be diagnosed with grade 1-3a follicular Lymphoma, Marginal zone lymphoma;

Previously untreated or relapsed or refractory patients;

Patients who started treatment with otuzumab between June 2021 and April 2023.

Disqualifiers

Patients currently participating or planning to participate in any interventional clinical trial;

Patients who, in the opinion of the investigator, are Discomfort for any other reason to participate in this study.

Trial population

patients with FL and MZL who started treatment with otuzumab between June 2021 and April 2023.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Obinutuzumab

    Drug

    obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Cohort 11 intervention
Group B: Cohort 21 intervention

Trial outcomes

Primary outcomes

1

Efficacy Endpoints

The best objective response rate (ORR), and CR rate; ORR and CR rate at the end of treatment; DCR, DoR, TTNT, PFS, DFS, and OS.

Time frame
12 months

Secondary outcomes

1

Safety Endpoints

All AEs, SAEs, Grade 3 AEs, and all other safety variables, including vital signs, Physical examination results, and laboratory parameters.

Time frame
12 months

Other outcomes

1

Exploratory Endpoints

Subgroup analyses will be performed for some special populations, such as in high-risk patients

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Affiliated Hospital of Nantong University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: