Diffuse Large B Cell LymphomaNCT03715296
Lenalidomide Based Immunotherapy in the Treatment of DLBCL
An observational study of Diffuse Large B Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This study is to evaluate the efficacy related molecular biomarker of Lenalidomide plus RCHOP or RICE in the treatment of de novo or Refractory and Relapsed DLBCL patients Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Lenalidomide 25mg
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2018to 15 Sep 2020
- How long will I take part?
- 2 Years
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: De novo DLBCL patients / Relapse Refractory DLBCL patients
Who may be able to join
- Histologically diagnosed as diffuse large b-cell lymphoma and may provide a desirable lymph node tissue sample (10 paraffin sections or rolls) or lymph node biopsy sample (15 paraffin sections or rolls)
- Previously treated with Lenalidomide plus RCHOP regimen in de novo DLBCL or Lenalidomide plus RICE regimen in relapse refractory DLBCL.
- 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
Weili ZHAO, MD, PhD, 86-21-64370045 ext. 610707, zhao.weili@yahoo.com
Shu CHENG, MD, PhD, 86-21-64370045 ext. 665251, orenge@medmail.com.cn
About this study
Official title: Lenalidomide Based Immunotherapy Efficacy Related Molecular Biomarker in Diffuse Large B-cell Lymphoma
This study is to evaluate the efficacy related molecular biomarker of Lenalidomide plus RCHOP or RICE in the treatment of de novo or Refractory and Relapsed DLBCL patients
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Lenalidomide 25mg
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide 25mgDrug
Lenalidomide 25mg/d PO d1-10 Plus Rituximab 375 mg/m2 IV d1, Cyclophosphamide 750mg/m2 IV d2, Doxorubicin 50mg/m2 IV d2, Vincristine 1.4 mg/m2 IV d2, Prednisone 60 mg/m2 PO d2-6 OR Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3,
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Measured: 12 weeks
Secondary outcomes (3)
Progression free survival rate
Measured: 1 year
Overall survival rate
Measured: 1 year
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 start18 Oct 2018
- Primary completion15 Sep 2020 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
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
- NCT03715296
- Sponsor's protocol ID
- NHL-007
- Status last verified
- Jul 2019
- First submitted
- 19 Oct 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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
- Lenalidomide Based Immunotherapy Efficacy Related Molecular Biomarker in Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT03715296
- Acronym / sponsor ID
- NHL-007
- Conditions
- Diffuse Large B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 15 Sep 2020 (estimated)
- Study completion
- 15 Sep 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.
This study is to evaluate the efficacy related molecular biomarker of Lenalidomide plus RCHOP or RICE in the treatment of de novo or Refractory and Relapsed DLBCL patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- De novo DLBCL patients / Relapse Refractory DLBCL patients
Key inclusion criteria (4 listed)
- Histologically diagnosed as diffuse large b-cell lymphoma and may provide a desirable lymph node tissue sample (10 paraffin sections or rolls) or lymph node biopsy sample (15 paraffin sections or rolls)
- Previously treated with Lenalidomide plus RCHOP regimen in de novo DLBCL or Lenalidomide plus RICE regimen in relapse refractory DLBCL.
- 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 |
|---|---|---|
| Lenalidomide 25mgLenalidomide 25mg/d PO d1-10 Plus Rituximab 375 mg/m2 IV d1, Cyclophosphamide 750mg/m2 IV d2, Doxorubicin 50mg/m2 IV d2, Vincristine 1.4 mg/m2 IV d2, Prednisone 60 mg/m2 PO d2-6 OR Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3, | Drug | – |
Primary outcome
Complete response rate
Time frame: 12 weeks
3 secondary outcomes
Progression free survival rate
Time frame: 1 year
Overall survival rate
Time frame: 1 year
Overall response rate
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.
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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 Diffuse Large B Cell 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 4 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.
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, MD, PhD (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?
Complete response rate (time frame: 12 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 8 Jul 2019.