NCT05318391

Brief Summary

The purpose of the study is to investigate the proportion of the cell-of-origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 14, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

May 8, 2021

Last Update Submit

March 31, 2022

Conditions

Lymphoma, Large B-Cell, DiffuseGene Expression Profiling

Keywords

Canhelp-COO Assay

Outcome Measures

Primary Outcomes (1)

  • proportion of the cell of origin subtypes in the study population

    Investigate the proportion of the cell of origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars.

    up to 24 weeks

Secondary Outcomes (2)

  • correlation between COO subtypes and the ORR of the treatment of R/R DLBCL.

    up to 24 weeks

  • correlation between COO subtypes and the PFS and OS of the treatment of R/R DLBCL.

    up to 24 weeks

Study Arms (1)

Group/Cohort

Retrospective Cohort： Participants who diagnosed with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) patients and treated with BTK inhibitor or lenalidomide and its biosimilars.

Diagnostic Test: Gene expression profile

Interventions

Gene expression profileDIAGNOSTIC_TEST

Diagnostic Test: The Canhelp-COO Assay (Canhelp Genomics CO., Ltd) for differentiating COO subtypes using gene expression analysis by real-time PCR (RT-PCR)

Group/Cohort

Eligibility Criteria

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

Relapsed/refractory DLBCL patients who had received BTK inhibitors and/or lenalidomide and its biosimilars after the failure of the first-line standard treatment.Patients with comprehensive history information and follow-up data and are able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research.

You may qualify if:

  • Histologically-confirmed diagnosis of DLBCL, including transformed large B-cell lymphoma from previous indolent lymphoma.
  • Meet the definition of relapsed/refractory DLBCL.
  • Patients received BTK inhibitors and/or lenalidomide and its biosimilars after the failure of the first-line standard treatment. The efficacy was evaluated by the investigators. Cohort plans to enroll one hundred patients with BTK inhibitors treatment (excluding the combination with lenalidomide), one hundred patients with lenalidomide treatment (excluding the combination with BTK inhibitors) and any number of the cases with BTK inhibitors and lenalidomide combination.
  • a) BTK inhibitors include ibrutinib, zanubrutinib and acalabrutinib
  • Patients with comprehensive history information and follow-up data.
  • Patient able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research.

You may not qualify if:

  • The archived tumor tissue is too little to test.
  • Patients with primary central nerve system large B-cell lymphoma or primary mediastinal large B-cell lymphoma.
  • R/R DLBCL patients receive BTK inhibitor or lenalidomide treatment for less than one cycle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yian Zhang

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Yan WH, Jiang XN, Wang WG, Sun YF, Wo YX, Luo ZZ, Xu QH, Zhou XY, Cao JN, Hong XN, Li XQ. Cell-of-Origin Subtyping of Diffuse Large B-Cell Lymphoma by Using a qPCR-based Gene Expression Assay on Formalin-Fixed Paraffin-Embedded Tissues. Front Oncol. 2020 Jun 5;10:803. doi: 10.3389/fonc.2020.00803. eCollection 2020.

    PMID: 32582543BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-Fixed and Parrffin-Embedded

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Transcriptome

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Transcription, GeneticBiochemical PhenomenaChemical PhenomenaGene ExpressionGenetic PhenomenaGenetic Structures

Study Officials

  • Peng Liu, MD,PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of hematology department

Study Record Dates

First Submitted

May 8, 2021

First Posted

April 8, 2022

Study Start

April 14, 2021

Primary Completion

January 30, 2022

Study Completion

March 30, 2022

Last Updated

April 8, 2022

Record last verified: 2022-03

Locations

CN(1)