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

Follicular Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05846763
• Other study ID #: BDHFL2023
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: May 31, 2028

Study information

• Verified date: April 2023
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: shuhua Yi, Dr
• Phone: 86-22-23909106
• Email: yishuhua[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Locations

Country	Name	City	State
China	Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate(ORR)	Proportion of patients with complete response (CR) and partial response (PR) after the end of induction therapy.	24 weeks
Secondary	2-year Progression free survival(PFS24)	Time to first disease progression or death from any cause within two years from enrollment.	Up to 4.5 years
Secondary	2-year Event-free survival(EFS24)	Time to any event, including disease progression, discontinuation of treatment for any reason, or death within two years from enrollment.	Up to 4.5 years
Secondary	Complete response (CR)	Proportion of patients with complete response at the end of treatment	2.5 years
Secondary	Duration of response (DoR)	Time from enrollment to disease progression or death for patients with a complete or partial response	Up to 4.5 years
Secondary	Overall survival (OS)	Time to death from any cause from the date of enrollment	Up to 4.5 years
Secondary	Safety(Proportion of Grade 3-4 Hematologic and Non-Hematologic Toxicities)	All hematological and non-hematological toxicities from enrollment to 28 days after the end of treatment	4.5 years