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Frontline of ASCT in High-risk DLBCL
RECRUITINGSponsored by Peking University People's Hospital
Actively Recruiting
SponsorPeking University People's Hospital
Started2023-05-03
Est. completion2025-04-27
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05831865
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
Age: 18 Years – 70 YearsHealthy volunteers accepted
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
Conditions2
CancerDiffuse Large B-Cell Lymphoma
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Actively Recruiting
SponsorPeking University People's Hospital
Started2023-05-03
Est. completion2025-04-27
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05831865