AzTrials
AzTrials

Follicular LymphomaPhase 4NCT04842318

Rituximab Maintenance Treatment of Newly Diagnosed Follicular Lymphoma After BR or RCHOP or R2: a Multicenter Clinical Study

A Phase 4 study testing BR for 6 cycles +R for 8 cycles, RCHOP for 6 cycles +R for 8 cycles and R2 for 6 cycles + R2 maintenance in people with Follicular Lymphoma, run by Ruijin Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This multi-center clinical study will evaluate the efficacy of Rituximab maintenance treatment of newly diagnosed follicular lymphoma after induction therapy of BR, RCHOP or R2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
BR for 6 cycles +R for 8 cycles, RCHOP for 6 cycles +R for 8 cycles and R2 for 6 cycles + R2 maintenance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
789 participants
Where
1 siteChina
Study dates
1 Mar 2021to 1 Mar 2024
Phase
Phase 4
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

  • Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
  • Treatment naive
  • Age ≥ 18 years
  • Indications for treatment confirmed
  • Must has measurable lesion in CT or PET-CT prior to treatment
  • Considered suitable for RCHOP, BR or R2 regimens
  • Informed consented

Who cannot join

  • Transformed follicular lymphoma or 3B follicular lymphoma;
  • HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive
  • Central nervous system or meninges involved
  • Any drug contraindication in the treatment plan
  • Patients judged by other researchers to be unsuitable for inclusion in the study

Trial locations and contacts

1 site in 1 country.

Weili Zhao, PhD, MD contact

+862164370045

zwl_trial@163.com

Pengpeng Xu, PhD, MD contact

+862164370045

pengpeng_xu@126.com

China1 site, 1 recruiting

  • Ruijin Hospital

    Shanghai

    Weili Zhao, +862164370045, zwl_trial@163.com

    Weili Zhao

    Recruiting

Other trials in China

About this study

Official title: Rituximab Maintenance Treatment of Newly Diagnosed Follicular Lymphoma After Induction Therapy of Rituximab Combined With Bendamustine (BR) or Cyclophosphamide, Vincristine, Doxorubicin, Prednisone (RCHOP) or Lenalidomide (R2): a Multicenter Clinical Study

This multi-center clinical study will evaluate the efficacy of Rituximab maintenance treatment of newly diagnosed follicular lymphoma after induction therapy of BR, RCHOP or R2.

Read the detailed description

Follicular lymphoma (FL) is a lymphoma of B cells in follicular center. It is a common pathological subtype of lymphoma, and its incidence rate is only next to diffuse large B cell lymphoma (DLBCL). The initial remission rate is high, but the tumor generally recurrent, making it difficult to be completely cured. This study attempts to explore the efficacy and safety of rituximab monotherapy maintenance after BR, RCHOP, R2 regimen induction therapy in the treatment of follicular patients, and to find the best way to maximize survival benefit and reduce treatment toxicity for FL patients. The study can improve the quality of life, prolong the survival and avoid the transformation to invasive lymphoma in patients with follicular lymphoma.

Being tested
BR for 6 cycles +R for 8 cycles, RCHOP for 6 cycles +R for 8 cycles, R2 for 6 cycles + R2 maintenance
Keywords
Follicular lymphoma, Rituximab, maintenance treatment
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BR for 6 cycles +R for 8 cyclesDrug

    The patients will be given Bendamustine (90mg/m2 d1,2, every 28 days for total 6 courses) combined with Rituximab (375mg/m2 d0, every 28 days for total 6 courses) followed by Rituximab (375mg/m2 d1, every 3 months for total 8 courses)

  • RCHOP for 6 cycles +R for 8 cyclesDrug

    The patients will be given RCHOP (Rituximab 375mg/m2 ivgtt, D0, Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1, Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses) followed by Rituximab (375mg/m2 d1, every 3 months for total 8 courses)

  • R2 for 6 cycles + R2 maintenanceDrug

    The patients will be given Lenalidomide (25mg/d, po, D1-10, every 21 days for total 6 courses) combined with Rituximab (375mg/m2 d0, every 21 days for total 6 courses) followed by Lenalidomide (25mg/d, po, D1-10, every 28 days for total 6 courses) combined with Rituximab (375mg/m2 d1, every 3 months for total 8 courses)

Study groups in NCT04842318
Study groupRoleWhat they receive
BR+RExperimentalInduction Therapy: Rituximab Combined With Bendamustine Maintenance Treatment: Rituximab
Receives: Drug: BR for 6 cycles +R for 8 cycles
RCHOP+RExperimentalInduction Therapy: Rituximab Combined With Cyclophosphamide, Vincristine, Doxorubicin, Prednisone Maintenance Treatment: Rituximab
Receives: Drug: RCHOP for 6 cycles +R for 8 cycles
R2+R2ExperimentalInduction Therapy: Lenalidomide Combined With Rituximab Maintenance Treatment: Lenalidomide Combined With Rituximab
Receives: Drug: R2 for 6 cycles + R2 maintenance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRD negative rate of bone marrow at 24 weeks

    Percentage of participants with negative MRD estimated by q-RT-PCR of bone marrow

    Measured: At 24 weeks

Secondary outcomes (10)

  1. Overall response rate

    Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria

    Measured: 21 days after 6 cycles of induction therapy (each cycle is 21 days)

  2. Overall survival

    Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  3. Progression of disease within 24 months

    Progression of disease within 24 months was defined as the rate of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

    Measured: Baseline up to data cut-off (24 months)

  4. Event-free survival

    Event-free survival was defined as the time from the date of diagnosis until the date of the first documented day of events.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  5. Time to Progression

    Time to Progression was defined as the time from the date of diagnosis until the date of the first documented day of disease progression, using 2014 Lugano criteria, whichever occurred first.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  6. Duration of response

    Duration of response was defined as the time from the date of diagnosis until the date of the first documented day of disease relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  7. Time to Next Anti-lymphoma Treatment

    Time to Next Anti-lymphoma Treatment was defined as the time from the date of first treatment until the date patients need to receive next anti-lymphoma treatment on the basis of investigator assessments according to 2014 Lugano criteria

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  8. Progression Free Survival

    Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  9. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events

    Measured: Up to 30 days after completion of study treatment

  10. MRD negative rate of peripheral blood at 24 weeks

    Percentage of participants with negative MRD estimated by q-RT-PCR of peripheral blood

    Measured: At 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2021
  2. Study start1 Mar 2021
  3. Primary completion1 Mar 2023 (estimated)
  4. Study completion1 Mar 2024 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
789 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04842318
Sponsor's protocol ID
FL-001
Status last verified
Apr 2021
First submitted
4 Apr 2021
Last updated
13 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BR for 6 cycles +R for 8 cycles, RCHOP for 6 cycles +R for 8 cycles and R2 for 6 cycles + R2 maintenance 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 7 inclusion and 5 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 13 Apr 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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, PhD, MD (+862164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRD negative rate of bone marrow at 24 weeks (time frame: At 24 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 NCT04842318.

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 13 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in