Primary Intraocular LymphomaPhase 2NCT03746223
Intravitreal Methotrexate and R2(Rituximab & Lenalidomide) Regimen in Newly-diagnosed Primary Vitreoretinal Lymphoma
A Phase 2 study testing Methotrexate, Rituximab and Lenalidomide in people with Primary Intraocular Lymphoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective single arm phase II study, and the purpose of this study is to evaluate the efficiency of R2 regimen (rituximab \& lenalidomide) combined with intravitreal methotrexate and followed by lenalidomide maintenance in newly-diagnosed primary intraocular lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Intraocular Lymphoma
- What is being tested?
- Methotrexate, Rituximab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2018to 15 Oct 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly-diagnosed primary vitreoretinal lymphoma
- ECOG≤2
- creatinine clearance rate (CCR) ≥ 60ml/h, according to Cockcroft-Gault
- Total bilirubin < 2 upper limits of normal, alanine aminotransferase（ALT） < 3 upper limits of normal
- Sign the Informed consent
- Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.
- Male subjects must agree to use condoms throughout study drug therapy.
Who cannot join
- primary central nervous system lymphoma involved eyes and brain
- systemic B cell lymphoma involved eyes
- Pre-existing uncontrolled active infection
- Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria
- Pregnancy or active lactation
- Co-existing tumors
- HIV（human immunodeficiency virus） or HBV（hepatitis B virus） or HCV（hepatitis C virus） infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union medical college hospital
Beijing, Beijing Municipality, 100730
Wei Zhang
About this study
Official title: Combined Intravitreal Methotrexate and R2 Regimen Followed by Lenalidomide Maintenance in Newly-diagnosed Primary Vitreoretinal Lymphoma
This is a prospective single arm phase II study, and the purpose of this study is to evaluate the efficiency of R2 regimen (rituximab \& lenalidomide) combined with intravitreal methotrexate and followed by lenalidomide maintenance in newly-diagnosed primary intraocular lymphoma. Progression free survival (PFS) of the cohort is the primary endpoint.
Read the detailed description
All the patients will be treated with R2 regimen （Rituximab 375mg/m2 IV d1, lenalidomide 25mg d1-21, 28 days per cycle) as induction regimen, meanwhile intravitreal methotrexate was given at a dose of 400ug for 16 doses.
The response will be evaluated every 3 cycles. After 3 Cycles, patients who achieved complete remission (CR) or partial remission (PR) will receive 3 more cycles of R2 regimen. The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens. After total 6 induction cycles, the investigators evaluate the efficiency again, the patients with CR or PR will go to lenalidomide maintenance for 2 years or until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion. And the patients with SD or PD will receive salvage regimen.
During following-up, surveillance ophthalmologic examination and brain magnetic resonance imaging (MRI) scans can be performed every 3 months up to the first 2 years, followed by doctor visit every 6 months up to 5 years or the disease relapses.
- Conditions
- Primary Intraocular Lymphoma
- Being tested
- Methotrexate, Rituximab, Lenalidomide
- Keywords
- intravitreal methotrexate injection, rituximab, lenalidomide, Primary vitreoretinal lymphoma
- Medical subject headings
- Intraocular Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
400ug intravitreal injection every week for 4 doses in the induction phase, every 2 weeks for 2 doses as consolidation, then every month for 10 doses as maintenance
RituximabDrug
Rituximab：375mg/m2 intravenous infusion d1, every 28 days for 1 cycle. 6 cycles will be prescribed as protocol
LenalidomideDrug
25mg Qd, oral , d1-21 in 28-day cycle in the induction phase and maintenance phase.
| Study group | Role | What they receive |
|---|---|---|
| R2-R/IV-MTX（methotrexate） | Experimental | experimental arm will be treated rituximab plus lenalidomide (R2) regimen for 6 cycles and followed by lenalidomide maintenance for 2 years, meanwhile intravitreal methotrexate will be given as protocol Receives: Drug: Methotrexate; Drug: Rituximab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 years progression-free survival
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
Measured: from the date of treatment to the subject finished his 2 years follow-up phase or the disease relapsed or the death due to lymphoma
Secondary outcomes (1)
overall response rate(ORR)
ORR was calculated by the proportion of patients who achieved complete remission and partial remission.
Measured: 4 weeks after the end of 6 cycles of induction (each cycle is 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start15 Nov 2018
- Primary completion15 Nov 2020 (estimated)
- Study completion15 Oct 2025 (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 Primary Intraocular LymphomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daobin Zhou, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746223
- Sponsor's protocol ID
- PUMCH-NHL-003
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Zhang X, Zou D, Yin J, Zhang L, Wang X, Jia C, Wang W, Zhao D, Zhou D, Zhang W, Zhang M. Lenalidomide and Rituximab Regimen Combined With Intravitreal Methotrexate Followed by Lenalidomide Maintenance for Primary Vitreoretinal Lymphoma: A Prospective Phase II Study. Front Oncol. 2021 Jun 24;11:701507. doi: 10.3389/fonc.2021.701507. eCollection 2021.
PubMed 34249763
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Intravitreal Methotrexate and R2 Regimen Followed by Lenalidomide Maintenance in Newly-diagnosed Primary Vitreoretinal Lymphoma
- ClinicalTrials.gov ID
- NCT03746223
- Acronym / sponsor ID
- PUMCH-NHL-003
- Conditions
- Primary Intraocular Lymphoma
- Keywords
- intravitreal methotrexate injection, rituximab, lenalidomide, Primary vitreoretinal lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 19 Nov 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.
This is a prospective single arm phase II study, and the purpose of this study is to evaluate the efficiency of R2 regimen (rituximab \& lenalidomide) combined with intravitreal methotrexate and followed by lenalidomide maintenance in newly-diagnosed primary intraocular lymphoma. Progression free survival (PFS) of the cohort is the primary endpoint.
Detailed description
All the patients will be treated with R2 regimen （Rituximab 375mg/m2 IV d1, lenalidomide 25mg d1-21, 28 days per cycle) as induction regimen, meanwhile intravitreal methotrexate was given at a dose of 400ug for 16 doses.
The response will be evaluated every 3 cycles. After 3 Cycles, patients who achieved complete remission (CR) or partial remission (PR) will receive 3 more cycles of R2 regimen. The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens. After total 6 induction cycles, the investigators evaluate the efficiency again, the patients with CR or PR will go to lenalidomide maintenance for 2 years or until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion. And the patients with SD or PD will receive salvage regimen.
During following-up, surveillance ophthalmologic examination and brain magnetic resonance imaging (MRI) scans can be performed every 3 months up to the first 2 years, followed by doctor visit every 6 months up to 5 years or the disease relapses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R2-R/IV-MTX（methotrexate） | Experimental | Drug: Methotrexate, Drug: Rituximab, Drug: Lenalidomideexperimental arm will be treated rituximab plus lenalidomide (R2) regimen for 6 cycles and followed by lenalidomide maintenance for 2 years, meanwhile intravitreal methotrexate will be given as protocol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly-diagnosed primary vitreoretinal lymphoma
- ECOG≤2
- creatinine clearance rate (CCR) ≥ 60ml/h, according to Cockcroft-Gault
- Total bilirubin < 2 upper limits of normal, alanine aminotransferase（ALT） < 3 upper limits of normal
- Sign the Informed consent
Key exclusion criteria (7 listed)
- primary central nervous system lymphoma involved eyes and brain
- systemic B cell lymphoma involved eyes
- Pre-existing uncontrolled active infection
- Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria
- Pregnancy or active lactation
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 |
|---|---|---|
| Methotrexate400ug intravitreal injection every week for 4 doses in the induction phase, every 2 weeks for 2 doses as consolidation, then every month for 10 doses as maintenance | Drug | R2-R/IV-MTX（methotrexate） |
| RituximabRituximab：375mg/m2 intravenous infusion d1, every 28 days for 1 cycle. 6 cycles will be prescribed as protocol | Drug | R2-R/IV-MTX（methotrexate） |
| Lenalidomide25mg Qd, oral , d1-21 in 28-day cycle in the induction phase and maintenance phase. | Drug | R2-R/IV-MTX（methotrexate） |
Primary outcome
2 years progression-free survival
Time frame: from the date of treatment to the subject finished his 2 years follow-up phase or the disease relapsed or the death due to lymphoma
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
1 secondary outcome
overall response rate(ORR)
Time frame: 4 weeks after the end of 6 cycles of induction (each cycle is 28 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Derived from this study: PubMed 34249763Zhang Y, Zhang X, Zou D, Yin J, Zhang L, Wang X, Jia C, Wang W, Zhao D, Zhou D, Zhang W, Zhang M. Lenalidomide and Rituximab Regimen Combined With Intravitreal Methotrexate Followed by Lenalidomide Maintenance for Primary Vitreoretinal Lymphoma: A Prospective Phase II Study. Front Oncol. 2021 Jun 24;11:701507. doi: 10.3389/fonc.2021.701507. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Daobin Zhou, MD principal investigator
Peking Union Medical College Hospital
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 Methotrexate, Rituximab and Lenalidomide in people with Primary Intraocular Lymphoma, run by Peking Union Medical College 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 7 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 9 Oct 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 Wei Zhang, MD (+86 136 8147 3557, vv1223@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 years progression-free survival (time frame: from the date of treatment to the subject finished his 2 years follow-up phase or the disease relapsed or the death due to lymphoma). 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 NCT03746223, 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 9 Oct 2019.