🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05831865
Recruiting Observational

Frontline of ASCT in High-risk DLBCL

NCT05831865 · tracked via the Priya Life Science China tracker
Sponsor
Peking University People's Hospital
Phase
Observational
Started
2023-05-03
Last updated
2023-05-06

Condition(s) studied

Diffuse Large B Cell Lymphoma

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Beijing Municipality Recruiting

More Peking University People's Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05831865 on ClinicalTrials.gov ↗ ← All trials in China