Recruiting NCT05846763

Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Follicular Lymphoma in Real World Study

— Observational Follicular Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Follicular Lymphoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Obinutuzumab in Combination With Lenalidomide in Patients With Relapsed and Refractory Follicular Lymphoma (R/R FL): A Prospective Observational Study

Overview

This study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with R/R FL in a real-world setting in a Chinese population.

Detailed description

Available data have shown that the combination of obinutuzumab and lenalidomide has shown good efficacy and safety in patients with R/R FL, but the efficacy and safety in Chinese patients remain to be verified.

The main questions it aims to answer are:

* To assess the ORR in the R/R FL patient population treated with the combination of obinutuzumab and lenalidomide * To assess CRR, PFS, EFS, DOR, OS, and safety in patients with R/R FL treated with the combination of obinutuzumab and lenalidomide

Participants in this study will not and should not result in any intervention to the patient's treatment and visits. All treatments and visits for patients will be at the physician's discretion according to clinical practice

Primary outcome measures

overall response rate（ORR） [Time frame: 24 weeks]

Secondary outcome measures (6)

2-year Progression free survival（PFS24） [Time frame: Up to 4.5 years]
2-year Event-free survival（EFS24） [Time frame: Up to 4.5 years]
Complete response (CR) [Time frame: 2.5 years]
Duration of response (DoR) [Time frame: Up to 4.5 years]
Overall survival (OS) [Time frame: Up to 4.5 years]
Safety(Proportion of Grade 3-4 Hematologic and Non-Hematologic Toxicities) [Time frame: 4.5 years]

Eligibility criteria

Patients must meet the following criteria for study entry::

Signed Informed Consent Form
Age ≥ 18 years at enrollment
At least one prior line of systemic (Stage III-IV) follicular lymphoma therapy
Relapsed or refractory to front-line anti-lymphoma therapy; refractory is defined as: tumor shrinkage of less than 50% or disease progression after 4 cycles of standard regimen chemotherapy; response to standard regimen chemotherapy, relapse within 24 months; 2 or more relapses, meeting one of the above criteria as refractory lymphoma.
Conditional treatment with obinutuzumab in combination with lenalidomide

Exclusion criteria

Patients currently participating or planning to participate in any interventional clinical trial
Any other reason that, in the opinion of the investigator, makes the patient unsuitable for this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

China · 1 center

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

Identifiers

NCT: NCT05846763 · BDHFL2023

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗