NCT05690191

Brief Summary

A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Trial Health

75
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress95%
Jun 2021Aug 2026

Study Start

First participant enrolled

June 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

5.2 years

First QC Date

December 5, 2022

Last Update Submit

January 9, 2023

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Objective response rates assessed by the investigator

    30 months

Secondary Outcomes (1)

  • Adverse Events

    30 months

Other Outcomes (3)

  • Complete response rate

    30 months

  • Progression-free survival

    30 months

  • Overall survival time

    30 months

Study Arms (1)

Chidamide in combination with rituximab and lenalidomide

Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses); Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle; Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle

Drug: ChidamideDrug: LenalidomideDrug: Rituximab

Interventions

ChidamideDRUG

Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses

Chidamide in combination with rituximab and lenalidomide
LenalidomideDRUG

Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle

Chidamide in combination with rituximab and lenalidomide
RituximabDRUG

Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle

Chidamide in combination with rituximab and lenalidomide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diffuse Large B-cell Lymphoma

You may qualify if:

  • The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
  • Age 18 and above, no gender limitation;
  • Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
  • Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion \> 1cm;
  • The serum pregnancy test of female subjects of childbearing age was negative;
  • Understand the test procedure and content, and sign the informed consent voluntarily.

You may not qualify if:

  • The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
  • Age 18 and above, no gender limitation;
  • Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
  • Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion \> 1cm;
  • The serum pregnancy test of female subjects of childbearing age was negative;
  • Understand the test procedure and content, and sign the informed consent voluntarily.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamideLenalidomideRituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Bingzong LI

    Second Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

January 19, 2023

Study Start

June 1, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations

CN(1)