Central Nervous System LymphomaPhase 2NCT04938297
Rituximab,Zanubrutinib in Combination With Lenalidomide, Followed by Zanubrutinib or Lenalidomide Maintenance in Patients With Primary or Secondary CNS Lymphoma
A Phase 2 study testing Rituximab, Lenalidomide, Zanubrutinib, Lenalidomide, Zanubrutinib and Lenalidomide in people with Central Nervous System Lymphoma, run by Henan Cancer Hospital at 1 site in China.
Trial summary
In view of the synergistic effects of rituximab, zanubrutinib, and lenalidomide and severe complications caused by current standard chemotherapy regimens in Patients for primary or secondary CNS lymphoma, we intend to conduct a prospective clinical study to evaluate the efficacy and toxicity of Rituximab, Zanubrutinib… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Lymphoma
- What is being tested?
- Rituximab, Lenalidomide, Zanubrutinib, Lenalidomide, Zanubrutinib and Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2021to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- voluntarily participate in clinical research, fully understand the study and sign the informed consent form (ICF), willing to follow and be able to complete all research steps
- histologically confirmed diffuse large B-cell lymphoma (DLBCL), all subjects must provide enough archived or fresh tumor tissue samples for immunhistochemistry (IHC) and gene expression profile (GEP) evaluation
- For untreated primary CNS lymphoma, patients should be with an age of 65 years or older, intolerable to first-line treatment
- Recurrent or refractory disease was defined as: 1) recurrence of disease after complete remission (CR), or 2) partial remission (PR), stable disease (SD), or progressive disease (PD) at the time of completion of treatment before inclusion
- Recurrent / refractory diffuse large B-cell lymphoma with CNS involvement confirmed by histopathology or imaging
- Age ≥ 18 years, ECoG score ≤ 2, expected survival time is more than 3 months
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- Patients with solid lesions must obtain clear evidence of disease progression through imaging examination (head MRI or head CT) 21 days before enrollment. For patients with leptomeningeal involvement only, CSF cytology examination must confirm lymphoma cells and / or imaging findings consistent with CSF disease 21 days before enrollment (at the discretion of the investigator)
- With sufficient organ and bone marrow function , and no severe hematopoietic, heart, lung, liver, kidney, thyroid dysfunction and immune deficiency
- at least 100 days after transplantation for recurrent patients after ATST
Who cannot join
- Histologically transformed large cell lymphoma
- History of previous transplantation of allogeneic stem cells
- Received BTKi or Lenalidomide
- Received corticosteroid within 7 days for antitumor treatment
- Received chemotherapy, radiotherapy, monoclonal antibody, experimental treatment, or traditional Chinese Medicine within 4 weeks
- Received major surgery within 4 weeks
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- Active malignant diseases within 2 years before entering the study
- Clinically significant cardiovascular diseases
- History of severe bleeding diseases
- history of stroke or intracranial hemorrhage within 6 months before the first administration
- Unable to swallow capsules or have diseases that significantly affect gastrointestinal function
- Uncontrolled systemic infection requiring parenteral anti infective therapy
- HIV infection or indicate active hepatitis B or C virus infection
- Drug allergies or metabolic disorders
- Pregnant or lactating women
- Any life-threatening diseases, medical conditions or organ system dysfunction that the researchers believe may affect the safety of the subjects or lead to research risks
- Required to continuously treated with potent and moderate CYP3A inhibitors or inducers
- History of deep venous thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan cancer hospital
Zhengzhou, Henan
Keshu Zhou, 13674902391, drzhouks77@163.com
About this study
In view of the synergistic effects of rituximab, zanubrutinib, and lenalidomide and severe complications caused by current standard chemotherapy regimens in Patients for primary or secondary CNS lymphoma, we intend to conduct a prospective clinical study to evaluate the efficacy and toxicity of Rituximab, Zanubrutinib in combination with Lenalidomide. Besides, the efficacy of Zanubrutinib or Lenalidomide in maintenance was also compared.
- Conditions
- Central Nervous System Lymphoma
- Being tested
- Rituximab, Lenalidomide, Zanubrutinib, Lenalidomide, Zanubrutinib, Lenalidomide
- Keywords
- Primary CNS Lymphoma, Zanubrutinib, Lenalidomide, Rituximab, Secondary CNS Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab, Lenalidomide, ZanubrutinibDrug
Induction therapy: Rituximab 375 mg / m2, day 1, Zanubrutinib 160 mg bid, orally, Lenalidomide 25mg QD, orally on day 1-21, 28 days as a course of treatment, 8 courses of treatment.
Lenalidomide, ZanubrutinibDrug
Maintenance therapy: Lenalidomide: 25mg qd (adjusted according to hectogram condition) or Zanubrutinib 160 mg bid. Continuously use for 2 years or until disease progression
LenalidomideDrug
Maintenance therapy: Lenalidomide: 25mg qd (adjusted according to hectogram condition) . Continuously use for 2 years or until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Primary CNS Lymphoma，age>65 | Experimental | 8 cycles of induction ZR2 , followed by Zanubrutinib or Lenalidomide maintenance for CR/PR fit patients through randomization by 1:1 ration Receives: Drug: Rituximab, Lenalidomide, Zanubrutinib; Drug: Lenalidomide, Zanubrutinib |
| Recurrent/refractory primary CNS lymphoma | Experimental | 8 cycles of induction ZR2, followed by Lenalidomide maintenance for CR/PR fit patients. Receives: Drug: Rituximab, Lenalidomide, Zanubrutinib; Drug: Lenalidomide |
| Recurrent/refractory diffuse large B-cell lymphoma with CNS invasion | Experimental | 8 cycles of induction ZR2, followed by Lenalidomide maintenance for CR/PR fit patients. Receives: Drug: Rituximab, Lenalidomide, Zanubrutinib; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
To evaluate the overall response rate of ZR2 in the treatment of CNS Lymphoma
Measured: at the end of 8 cycles of induction therapy (each cycle is 28 days)
Secondary outcomes (4)
Overall response rate
Measured: at the end of 4 cycles of induction therapy (each cycle is 28 days) and 1 year of maintenance therapy
Progression-free survival (PFS) rate
Measured: at the end of 8 cycles of induction therapy (each cycle is 28 days), 1 year and 2 year of maintenance therapy
Overall survival（OS）rate
Measured: at the end of 8 cycles of induction therapy (each cycle is 28 days), 1 year and 2 year of maintenance therapy
Treatment related adverse events
Measured: at the end of 8 cycles of induction therapy (each cycle is 28 days), 1 year and 2 year of maintenance therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start26 May 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, zhoukeshu, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938297
- Sponsor's protocol ID
- ZR2 for PCNSL/SCNSL
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab,Zanubrutinib in Combination With Lenalidomide, Followed by Zanubrutinib or Lenalidomide Maintenance in Patients With Primary or Secondary CNS Lymphoma
- ClinicalTrials.gov ID
- NCT04938297
- Acronym / sponsor ID
- ZR2 for PCNSL/SCNSL
- Conditions
- Central Nervous System Lymphoma
- Keywords
- Primary CNS Lymphoma, Zanubrutinib, Lenalidomide, Rituximab, Secondary CNS Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 26 May 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jun 2021 (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.
In view of the synergistic effects of rituximab, zanubrutinib, and lenalidomide and severe complications caused by current standard chemotherapy regimens in Patients for primary or secondary CNS lymphoma, we intend to conduct a prospective clinical study to evaluate the efficacy and toxicity of Rituximab, Zanubrutinib in combination with Lenalidomide. Besides, the efficacy of Zanubrutinib or Lenalidomide in maintenance was also compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary CNS Lymphoma，age>65 | Experimental | Drug: Rituximab, Lenalidomide, Zanubrutinib, Drug: Lenalidomide, Zanubrutinib8 cycles of induction ZR2 , followed by Zanubrutinib or Lenalidomide maintenance for CR/PR fit patients through randomization by 1:1 ration |
| Recurrent/refractory primary CNS lymphoma | Experimental | Drug: Rituximab, Lenalidomide, Zanubrutinib, Drug: Lenalidomide8 cycles of induction ZR2, followed by Lenalidomide maintenance for CR/PR fit patients. |
| Recurrent/refractory diffuse large B-cell lymphoma with CNS invasion | Experimental | Drug: Rituximab, Lenalidomide, Zanubrutinib, Drug: Lenalidomide8 cycles of induction ZR2, followed by Lenalidomide maintenance for CR/PR fit patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- voluntarily participate in clinical research, fully understand the study and sign the informed consent form (ICF), willing to follow and be able to complete all research steps
- histologically confirmed diffuse large B-cell lymphoma (DLBCL), all subjects must provide enough archived or fresh tumor tissue samples for immunhistochemistry (IHC) and gene expression profile (GEP) evaluation
- For untreated primary CNS lymphoma, patients should be with an age of 65 years or older, intolerable to first-line treatment
- Recurrent or refractory disease was defined as: 1) recurrence of disease after complete remission (CR), or 2) partial remission (PR), stable disease (SD), or progressive disease (PD) at the time of completion of treatment before inclusion
- Recurrent / refractory diffuse large B-cell lymphoma with CNS involvement confirmed by histopathology or imaging
Key exclusion criteria (18 listed)
- Histologically transformed large cell lymphoma
- History of previous transplantation of allogeneic stem cells
- Received BTKi or Lenalidomide
- Received corticosteroid within 7 days for antitumor treatment
- Received chemotherapy, radiotherapy, monoclonal antibody, experimental treatment, or traditional Chinese Medicine within 4 weeks
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 |
|---|---|---|
| Rituximab, Lenalidomide, ZanubrutinibInduction therapy: Rituximab 375 mg / m2, day 1, Zanubrutinib 160 mg bid, orally, Lenalidomide 25mg QD, orally on day 1-21, 28 days as a course of treatment, 8 courses of treatment. | Drug | Primary CNS Lymphoma，age>65, Recurrent/refractory diffuse large B-cell lymphoma with CNS invasion, Recurrent/refractory primary CNS lymphoma |
| Lenalidomide, ZanubrutinibMaintenance therapy: Lenalidomide: 25mg qd (adjusted according to hectogram condition) or Zanubrutinib 160 mg bid. Continuously use for 2 years or until disease progression | Drug | Primary CNS Lymphoma，age>65 |
| LenalidomideMaintenance therapy: Lenalidomide: 25mg qd (adjusted according to hectogram condition) . Continuously use for 2 years or until disease progression | Drug | Recurrent/refractory diffuse large B-cell lymphoma with CNS invasion, Recurrent/refractory primary CNS lymphoma |
Primary outcome
Overall response rate
Time frame: at the end of 8 cycles of induction therapy (each cycle is 28 days)
To evaluate the overall response rate of ZR2 in the treatment of CNS Lymphoma
4 secondary outcomes
Overall response rate
Time frame: at the end of 4 cycles of induction therapy (each cycle is 28 days) and 1 year of maintenance therapy
Progression-free survival (PFS) rate
Time frame: at the end of 8 cycles of induction therapy (each cycle is 28 days), 1 year and 2 year of maintenance therapy
Overall survival（OS）rate
Time frame: at the end of 8 cycles of induction therapy (each cycle is 28 days), 1 year and 2 year of maintenance therapy
Treatment related adverse events
Time frame: at the end of 8 cycles of induction therapy (each cycle is 28 days), 1 year and 2 year of maintenance therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 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.
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 Rituximab, Lenalidomide, Zanubrutinib, Lenalidomide, Zanubrutinib and Lenalidomide in people with Central Nervous System Lymphoma, run by Henan Cancer 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 9 inclusion and 18 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 24 Jun 2021. 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 Keshu Zhou, Dr. (13674902391, drzhouks77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: at the end of 8 cycles of induction therapy (each cycle is 28 days)). 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 24 Jun 2021.