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Completed

NCT Number: NCT05318391

Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yian Zhang

Shanghai, Shanghai Municipality, 200032, China

About this study

This is a multi-center, observational, retrospective study that examines approximately 200 R/R DLBCL patients treated with BTK inhibitors or lenalidomide and its biosimilars. For patients meet the inclusion criteria, gene expression analysis is performed on formalin fixed paraffin-embedded tissue by using Canhelp-COO Assay, and determine the COO subtype for each specimen. The proportion of COO subtypes in R/R DLBCL and the correlation between COO subtypes and clinicopathological information are further analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Gene expression profile

Diagnostic 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)

Primary outcomes

  1. proportion of the cell of origin subtypes in the study population

    Time frame: up to 24 weeks

    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.

Secondary outcomes

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

    Time frame: up to 24 weeks

    Based on the objective response rate (ORR) measured by the investigator, explore the correlation between COO subtypes and the efficacy of BTK inhibitors, lenalidomide and its biosimilars in the treatment of R/R DLBCL.

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

    Time frame: up to 24 weeks

    Based on the progression-free survival (PFS) and overall survival (OS) measuredd by the investigator, explore the correlation between COO subtypes and the efficacy of BTK inhibitors, lenalidomide and its biosimilars in the treatment of R/R DLBCL .

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Shanghai Minhang Central Hospital
  • Wuxi People's Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2022
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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