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Trial Title:
Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Follicular Lymphoma in Real World Study
NCT ID:
NCT05846763
Condition:
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Conditions: Keywords:
follicular lymphoma
Obinutuzumab
Lenalidomide
real-world
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
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.
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
Criteria for eligibility:
Study pop:
This study will include the population of patients with relapsed and refractory
follicular lymphoma who are planned to receive the combination of obinutuzumab and
Lenalidomide in 9 centers (including 8 sub-centers outside of the Institute of Hematology
& Blood Diseases Hospital )
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Rui Lyu
Phone:
86-22-23909106
Start date:
November 1, 2022
Completion date:
May 31, 2028
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05846763
