Non-hodgkin Lymphoma,B CellNCT04435743
Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin's Lymphomas
An observational study of Non-hodgkin Lymphoma,B Cell, run by Ruijin Hospital at 1 site in China.
Trial summary
Describe the treatment of B-cell non-Hodgkin lymphoma patients who receive lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs), and evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hodgkin Lymphoma,B Cell
- What is being tested?
- Lenalidomide
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to Dec 2022
- Phase
- Observational
- 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
Study population: This study focus on patients diagnosed with B-cell non-Hodgkin's lymphoma and treated with lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.
Who may be able to join
- Diagnosed as B-cell non-Hodgkin's lymphoma
- Voluntary participation in this study and the signing of an informed consent form
- The researchers assessed that the patient will benefit from the treatment of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs)
Who cannot join
- Contradictions to any drug in the treatment regimen
- Pregnant or lactating women
- Patients who were not considered suitable for the study by the researchers
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospital
Shanghai
Weili Zhao, M.D. and Ph.D, 13512112076, zhao.weili@yahoo.com
About this study
Official title: The Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin Lymphomas: a Real-world Study.
Describe the treatment of B-cell non-Hodgkin lymphoma patients who receive lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs), and evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.
Read the detailed description
This is a multi-center prospective, observational real-world study, targeting patients with B-cell non-Hodgkin's lymphomas. This study is designed to evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.
This study will mainly focus on the following three cohorts:
Cohort 1: patients diagnosed with CD20-positive diffuse large B-cell lymphoma; Cohort 2: patients diagnosed with CD20-positive follicle lymphoma; Cohort 3: patients on maintenance treatment who have achieved complete remission or partial remission after induction therapy.
- Conditions
- Non-hodgkin Lymphoma,B Cell
- Being tested
- Lenalidomide
- Keywords
- lenalidomide, Non-hodgkin Lymphoma,B Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Lenalidomide is given as any following dosage:
- 25mg, PO QD, Day 1-10 in every 21 days for 6 cycles;
- 15mg, PO QD, Day 1-14 in every 21 days for 6 cycles;
- 25mg, PO QD, Day 1-10 in every 21 days for 1 year;
- 25mg, PO QD, Day 1-21 in every 28 days for 1 year;
- 25mg, PO QD, Day 1-10 in every 28 days for 12 cycles;
- 20mg, PO QD, Day 1-21 in every 28 days for 12 cycles.
| Study group | Role | What they receive |
|---|---|---|
| DLBCL | Treatment-naive or relapsed/refractory CD20+ diffuse large B-cell lymphoma patients who receive induction therapy containing lenalidomide. Receives: Drug: Lenalidomide | |
| FL/MCL/MZL | Treatment-naive or relapsed/refractory CD20+ follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma patients who receive induction therapy containing lenalidomide. Receives: Drug: Lenalidomide | |
| Maintenance | B-cell non-Hodgkin lymphoma patients who achieve complete or partial remission after induction therapy and receive maintenance therapy containing lenalidomide. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Rate of objective response, defined according to Lugano 2014 criterion.
Measured: At the end of Cycle 6 (each cycle is 21-28 days)
Secondary outcomes (8)
Complete response rate
Rate of complete response, defined according to Lugano 2014 criterion
Measured: At the end of Cycle 6 (each cycle is 21-28 days)
Partial response rate
Rate of partial response, defined according to Lugano 2014 criterion
Measured: At the end of Cycle 6 (each cycle is 21-28 days)
Duration of response
Time to relapse or progression, measured from documentation of response, in CR or PR patients
Measured: From response evaluation to study completion, an average of 2 years.
2-year progression-free survival
The rate of patients who are free of disease progression or death as a result of any cause, measured from entry onto study, in all patients
Measured: 2 years after entry onto study
Overall survival
Death as a result of any cause, measured from entry onto study, in all patients
Measured: From entry onto study to study completion, an average of 2 years.
Adverse event
any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Measured: From entry onto study to study completion, an average of 2 years.
Severe adverse event
An adverse event when the patient outcome is death, life-threatening, required intervention to prevent permanent impairment or damage, hospitalization, disability or permanent damage, congenital anomaly or birth defect, or other important medical events
Measured: From entry onto study to study completion, an average of 2 years.
Dosage adjustment
Measured: From entry onto study to study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Nov 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin Lymphoma,B CellStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 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
- NCT04435743
- Sponsor's protocol ID
- LEN-NHL
- Status last verified
- Jul 2020
- First submitted
- 20 May 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin Lymphomas: a Real-world Study.
- ClinicalTrials.gov ID
- NCT04435743
- Acronym / sponsor ID
- LEN-NHL
- Conditions
- Non-hodgkin Lymphoma,B Cell
- Keywords
- lenalidomide, Non-hodgkin Lymphoma,B Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Jun 2020 (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.
Describe the treatment of B-cell non-Hodgkin lymphoma patients who receive lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs), and evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.
Detailed description
This is a multi-center prospective, observational real-world study, targeting patients with B-cell non-Hodgkin's lymphomas. This study is designed to evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.
This study will mainly focus on the following three cohorts:
Cohort 1: patients diagnosed with CD20-positive diffuse large B-cell lymphoma; Cohort 2: patients diagnosed with CD20-positive follicle lymphoma; Cohort 3: patients on maintenance treatment who have achieved complete remission or partial remission after induction therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DLBCL | – | Drug: LenalidomideTreatment-naive or relapsed/refractory CD20+ diffuse large B-cell lymphoma patients who receive induction therapy containing lenalidomide. |
| FL/MCL/MZL | – | Drug: LenalidomideTreatment-naive or relapsed/refractory CD20+ follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma patients who receive induction therapy containing lenalidomide. |
| Maintenance | – | Drug: LenalidomideB-cell non-Hodgkin lymphoma patients who achieve complete or partial remission after induction therapy and receive maintenance therapy containing lenalidomide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study focus on patients diagnosed with B-cell non-Hodgkin's lymphoma and treated with lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.
Key inclusion criteria (3 listed)
- Diagnosed as B-cell non-Hodgkin's lymphoma
- Voluntary participation in this study and the signing of an informed consent form
- The researchers assessed that the patient will benefit from the treatment of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs)
Key exclusion criteria (3 listed)
- Contradictions to any drug in the treatment regimen
- Pregnant or lactating women
- Patients who were not considered suitable for the study by the researchers
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 |
|---|---|---|
| LenalidomideLenalidomide is given as any following dosage: 1. 25mg, PO QD, Day 1-10 in every 21 days for 6 cycles; 2. 15mg, PO QD, Day 1-14 in every 21 days for 6 cycles; 3. 25mg, PO QD, Day 1-10 in every 21 days for 1 year; 4. 25mg, PO QD, Day 1-21 in every 28 days for 1 year; 5. 25mg, PO QD, Day 1-10 in every 28 days for 12 cycles; 6. 20mg, PO QD, Day 1-21 in every 28 days for 12 cycles. | Drug | DLBCL, FL/MCL/MZL, Maintenance |
Primary outcome
Objective response rate
Time frame: At the end of Cycle 6 (each cycle is 21-28 days)
Rate of objective response, defined according to Lugano 2014 criterion.
8 secondary outcomes
Complete response rate
Time frame: At the end of Cycle 6 (each cycle is 21-28 days)
Partial response rate
Time frame: At the end of Cycle 6 (each cycle is 21-28 days)
Duration of response
Time frame: From response evaluation to study completion, an average of 2 years.
2-year progression-free survival
Time frame: 2 years after entry onto study
Overall survival
Time frame: From entry onto study to study completion, an average of 2 years.
Adverse event
Time frame: From entry onto study to study completion, an average of 2 years.
Severe adverse event
Time frame: From entry onto study to study completion, an average of 2 years.
Dosage adjustment
Time frame: From entry onto study to study completion, an average of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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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?
An observational study of Non-hodgkin Lymphoma,B Cell, 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 3 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 7 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao, M.D. and Ph.D (+8613512112076, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: At the end of Cycle 6 (each cycle is 21-28 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 7 Jul 2020.