RecruitingNCT05831865

Frontline of ASCT in High-risk DLBCL

The Efficacy and Safety of Autologous Stem Cell Transplantation (ASCT) in Frontline Therapy of Patients With High-Risk Diffuse Large B-Cell Lymphoma

Sponsor

Peking University People's Hospital

Enrollment

175 participants

Start Date

May 3, 2023

Study Type

OBSERVATIONAL

Conditions

Diffuse Large B Cell Lymphoma

Summary

The role of frontline therapy of autologous stem cell transplant (ASCT) in diffuse large B-cell lymphoma (DLBCL) is controversial. The investigators aim to conduct this prospective study to observe the efficacy and safety of ASCT as frontline therapy in DLBCL patients with high-risk disease, defined by an International Prognostic Index (IPI) score equal to or greater than three.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

Previously untreated participants with cluster of differentiation 20 (CD20)-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS) including germinal center B-cell type, activated B-cell type; T-cell/histiocyte-rich large B-cell lymphoma; Epstein-Barr virus-positive DLBCL, NOS; anaplastic lymphoma kinase (ALK)-positive large B-cell lymphoma; human herpesvirus-8 (HHV8)-positive DLBCL, NOS; High-grade B-cell lymphoma with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma); High-grade B-cell lymphoma, NOS
Measurable tumor assessed by Lugano Response Criteria
International Prognostic Index (IPI) score equal to or greater than 3 points
Adequate hematologic function
Adequate liver function
Adequate kidney function
Left ventricular ejection fraction (LVEF) \>/= 50 percent (%) on cardiac echocardiogram (ECHO)

Exclusion Criteria3

Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
Participants with central nervous system (CNS) lymphoma (primary or secondary involvement)
History of other malignancy that could affect compliance with the protocol or interpretation of results