Clinical trial NCT05318391: Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma
Official title: Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Large B-Cell, Diffuse
Gene Expression Profiling
Keywords: Canhelp-COO Assay
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Wuxi People's Hospital
name: Shanghai Minhang Central Hospital
First posted: 2022-04-08
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Histologically-confirmed diagnosis of DLBCL, including transformed large B-cell lymphoma from previous indolent lymphoma.
2. Meet the definition of relapsed/refractory DLBCL.
3. 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
4. Patients with comprehensive history information and follow-up data.
5. Patient able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research.

Exclusion Criteria:

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

Primary outcomes:
measure: proportion of the cell of origin subtypes in the study population
timeFrame: up to 24 weeks
Secondary outcomes:
measure: correlation between COO subtypes and the ORR of the treatment of R/R DLBCL.
timeFrame: up to 24 weeks
measure: correlation between COO subtypes and the PFS and OS of the treatment of R/R DLBCL.
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yian Zhang
state: Shanghai
Study officials:
affiliation: Fudan University
name: Peng Liu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.