Follicular LymphomaPhase 2NCT03715309
R2 in the Treatment of Follicular Lymphoma
A Phase 2 study testing Revlimid in people with Follicular Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
Lenalidomide Based Immunotherapy in the Treatment of FL Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Revlimid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 1 Nov 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnose as de novo or relapse refractory FL grade 1-3A .
- No history of stem cell transplantation.
- Written informed consent.
Who cannot join
- Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
- Clinically significant active infection.
- Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
- Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
- Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
- Patients who are pregnant or breast-feeding.
- HIV infection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Zhong Zheng, 64370045
About this study
Official title: R2 in the Treatment of Follicular Lymphoma Grade 1-3A
Lenalidomide Based Immunotherapy in the Treatment of FL
Read the detailed description
Lenalidomide Based Immunotherapy efficacy related molecular biomarker in follicular lymphoma
- Conditions
- Follicular Lymphoma
- Being tested
- Revlimid
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevlimidDrug
Also called lenalidomide
Revlimid 25mg PO d1-10 Plus Rituximab 375 mg/m2 IV d0
| Study group | Role | What they receive |
|---|---|---|
| Revlimd | Experimental | Not described Receives: Drug: Revlimid |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR
Complete response rate
Measured: 12 weeks
Secondary outcomes (3)
PFS
Progression free survival rate
Measured: 1 year
OS
Overall survival rate
Measured: 1 year
ORR
Overall response rate
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Nov 2018
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715309
- Sponsor's protocol ID
- RJ-R2
- Status last verified
- Jul 2019
- First submitted
- 19 Oct 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng Z, Wang JB, Sun R, Wang N, Weng XQ, Xu TY, Fu D, Feng Y, Xu PP, Cheng S, Wang L, Zhao Y, Qu B, Huang CX, Zhao WL. Dual targeting PD-L1 and 4-1BB to overcome dendritic cell-mediated lenalidomide resistance in follicular lymphoma. Signal Transduct Target Ther. 2025 Jan 20;10(1):29. doi: 10.1038/s41392-024-02105-7.
PubMed 39828715
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R2 in the Treatment of Follicular Lymphoma Grade 1-3A
- ClinicalTrials.gov ID
- NCT03715309
- Acronym / sponsor ID
- RJ-R2
- Conditions
- Follicular Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 23 Oct 2018 (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.
Lenalidomide Based Immunotherapy in the Treatment of FL
Detailed description
Lenalidomide Based Immunotherapy efficacy related molecular biomarker in follicular lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revlimd | Experimental | Drug: Revlimid |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnose as de novo or relapse refractory FL grade 1-3A .
- No history of stem cell transplantation.
- Written informed consent.
Key exclusion criteria (7 listed)
- Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
- Clinically significant active infection.
- Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
- Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
- Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RevlimidAlso: lenalidomideRevlimid 25mg PO d1-10 Plus Rituximab 375 mg/m2 IV d0 | Drug | Revlimd |
Primary outcome
CR
Time frame: 12 weeks
Complete response rate
3 secondary outcomes
PFS
Time frame: 1 year
OS
Time frame: 1 year
ORR
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Derived from this study: PubMed 39828715Zheng Z, Wang JB, Sun R, Wang N, Weng XQ, Xu TY, Fu D, Feng Y, Xu PP, Cheng S, Wang L, Zhao Y, Qu B, Huang CX, Zhao WL. Dual targeting PD-L1 and 4-1BB to overcome dendritic cell-mediated lenalidomide resistance in follicular lymphoma. Signal Transduct Target Ther. 2025 Jan 20;10(1):29. doi: 10.1038/s41392-024-02105-7.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Revlimid in people with Follicular Lymphoma, run by Ruijin Hospital 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Jul 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao (+86 64370045 ext. 610707, Zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03715309, which also lists 1 linked publication.
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 8 Jul 2019.