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

NCT ID: NCT05846763

Last Updated: 2023-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2028-05-31

Brief Summary

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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

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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

Conditions

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Follicular Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shuhua Yi, Dr

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, Chinese

Locations

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

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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shuhua Yi, Dr

Role: CONTACT

86-22-23909106

Lugui Qiu, Dr

Role: CONTACT

86-22-23909172

Facility Contacts

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Rui Lyu

Role: primary

86-22-23909106

Other Identifiers

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BDHFL2023

Identifier Type: -

Identifier Source: org_study_id

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