NCT04842318

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
789

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

April 4, 2021

Last Update Submit

April 10, 2021

Conditions

Follicular Lymphoma

Keywords

Follicular lymphomaRituximabmaintenance treatment

Outcome Measures

Primary Outcomes (1)

  • MRD negative rate of bone marrow at 24 weeks

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

    At 24 weeks

Secondary Outcomes (10)

  • Overall response rate

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

  • Overall survival

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

  • Progression of disease within 24 months

    Baseline up to data cut-off (24 months)

  • Event-free survival

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

  • Time to Progression

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

  • +5 more secondary outcomes

Study Arms (3)

BR+R

EXPERIMENTAL

Induction Therapy: Rituximab Combined With Bendamustine Maintenance Treatment: Rituximab

Drug: BR for 6 cycles +R for 8 cycles

RCHOP+R

EXPERIMENTAL

Induction Therapy: Rituximab Combined With Cyclophosphamide, Vincristine, Doxorubicin, Prednisone Maintenance Treatment: Rituximab

Drug: RCHOP for 6 cycles +R for 8 cycles

R2+R2

EXPERIMENTAL

Induction Therapy: Lenalidomide Combined With Rituximab Maintenance Treatment: Lenalidomide Combined With Rituximab

Drug: R2 for 6 cycles + R2 maintenance

Interventions

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)

BR+R
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)

RCHOP+R
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)

R2+R2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Weili Zhao, PhD, MD

CONTACT

+862164370045zwl_trial@163.com

Pengpeng Xu, PhD, MD

CONTACT

+862164370045pengpeng_xu@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
First Deputy Director, Hematology Department

Study Record Dates

First Submitted

April 4, 2021

First Posted

April 13, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2024

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)