Actively Recruiting

Age: 18Years - 70Years
All Genders
NCT05831865

Frontline of ASCT in High-risk DLBCL

Led by Peking University People's Hospital · Updated on 2023-05-06

175

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

Sponsors

P

Peking University People's Hospital

Lead Sponsor

P

Peking University Cancer Hospital & Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Frontline of ASCT in High-risk DLBCL

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, Beijing Municipality, China, 010

Actively Recruiting

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Research Team

X

Xuelin Dou, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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