Clinical trial Recruiting at 1 site Observational Ages 18 and up

Combining obinutuzumab and lenalidomide for treating relapsed follicular lymphoma

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

Run by Institute of Hematology & Blood Diseases Hospital, China · NCT05846763 · Data updated 2026-11-12

This study is testing if combining obinutuzumab and lenalidomide can help people in China with relapsed follicular lymphoma feel better and live longer, while keeping their current treatment plans.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorInstitute of Hematology & Blood Diseases Hospital, China
Academic / other
Drugs / interventionsobinutuzumab, chemotherapy
Locations1 site (Tianjin)
StatusRecruiting
StartedNovember 1, 2022
Main results expectedMay 31, 2026
Study endsMay 31, 2028
Registry record updatedMay 23, 2023
Trial IDNCT05846763 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with a history of at least one prior line of systemic therapy for follicular lymphoma who are relapsed or refractory to previous treatments.

Probably not a fit

Patients currently participating in interventional clinical trials or deemed unsuitable by the investigator will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the efficacy and safety of obinutuzumab in combination with lenalidomide for patients with relapsed or refractory follicular lymphoma (R/R FL) in a real-world setting in China. It will assess various outcomes including overall response rate (ORR), complete response rate (CRR), progression-free survival (PFS), event-free survival (EFS), duration of response (DOR), overall survival (OS), and safety. The study will not involve any changes to the patients' treatment plans, as all interventions will be at the discretion of their physicians. The goal is to verify the previously observed efficacy and safety of this combination specifically in the Chinese patient population.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into effective treatment options for patients with relapsed or refractory follicular lymphoma.

How similar studies have gone: Previous studies have indicated good efficacy and safety of the obinutuzumab and lenalidomide combination, but this specific study aims to confirm these findings in a Chinese population.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

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

Study contacts

  • Principal investigator: Shuhua Yi, Dr — Institute of Hematology & Blood Diseases Hospital, Chinese
  • Study coordinator: shuhua Yi, Dr
  • Email: yishuhua@ihcams.ac.cn
  • Phone: 86-22-23909106

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.