Follicular LymphomaNCT05846763
Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Follicular Lymphoma in Real World Study
An observational study of Follicular Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 )
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, 300020
Rui Lyu, 86-22-23909106
About this study
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
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.
Read the 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
- Conditions
- Follicular Lymphoma
- Keywords
- follicular lymphoma, Obinutuzumab, Lenalidomide, real-world
- Medical subject headings
- Lymphoma, Follicular
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate（ORR）
Proportion of patients with complete response (CR) and partial response (PR) after the end of induction therapy.
Measured: 24 weeks
Secondary outcomes (6)
2-year Progression free survival（PFS24）
Time to first disease progression or death from any cause within two years from enrollment.
Measured: Up to 4.5 years
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.
Measured: Up to 4.5 years
Complete response (CR)
Proportion of patients with complete response at the end of treatment
Measured: 2.5 years
Duration of response (DoR)
Time from enrollment to disease progression or death for patients with a complete or partial response
Measured: Up to 4.5 years
Overall survival (OS)
Time to death from any cause from the date of enrollment
Measured: Up to 4.5 years
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
Measured: 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Nov 2022
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuhua Yi, Dr, Principal investigator, Institute of Hematology & Blood Diseases Hospital, Chinese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846763
- Sponsor's protocol ID
- BDHFL2023
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05846763
- Acronym / sponsor ID
- BDHFL2023
- Conditions
- Follicular Lymphoma
- Keywords
- follicular lymphoma, Obinutuzumab, Lenalidomide, real-world
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 )
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall response rate（ORR）
Time frame: 24 weeks
Proportion of patients with complete response (CR) and partial response (PR) after the end of induction therapy.
6 secondary outcomes
2-year Progression free survival（PFS24）
Time frame: Up to 4.5 years
2-year Event-free survival（EFS24）
Time frame: Up to 4.5 years
Complete response (CR)
Time frame: 2.5 years
Duration of response (DoR)
Time frame: Up to 4.5 years
Overall survival (OS)
Time frame: Up to 4.5 years
Safety(Proportion of Grade 3-4 Hematologic and Non-Hematologic Toxicities)
Time frame: 4.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuhua Yi, Dr principal investigator
Institute of Hematology & Blood Diseases Hospital, Chinese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shuhua Yi, Dr (86-22-23909106, yishuhua@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate（ORR） (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.