Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, 300020, China
Location status: Recruiting
NCT Number: NCT05846763
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Tianjin, 300020, China
Location status: Recruiting
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:
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patients must meet the following criteria for study entry::
Exclusion criteria
Time frame: 24 weeks
Proportion of patients with complete response (CR) and partial response (PR) after the end of induction therapy.
Time frame: Up to 4.5 years
Time to first disease progression or death from any cause within two years from enrollment.
Time frame: Up to 4.5 years
Time to any event, including disease progression, discontinuation of treatment for any reason, or death within two years from enrollment.
Time frame: 2.5 years
Proportion of patients with complete response at the end of treatment
Time frame: Up to 4.5 years
Time from enrollment to disease progression or death for patients with a complete or partial response
Time frame: Up to 4.5 years
Time to death from any cause from the date of enrollment
Time frame: 4.5 years
All hematological and non-hematological toxicities from enrollment to 28 days after the end of treatment
Contact information is provided by the study sponsor or research team.
Lugui Qiu, Dr
CONTACT
shuhua Yi, Dr
CONTACT
Institute of Hematology & Blood Diseases Hospital, China
Other
Efficacy and Safety of Obinutuzumab in Combination With Lenalidomide in Patients With Relapsed and Refractory Follicular Lymphoma (R/R FL): A Prospective Observational Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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