Clinical trial Recruiting at 1 site Observational Ages 18 to 70

Evaluating autologous stem cell transplant for high-risk diffuse large B-cell lymphoma

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

Run by Peking University People's Hospital · NCT05831865 · Data updated 2026-11-12

This study is testing if using a stem cell transplant after standard chemotherapy can help people with high-risk diffuse large B-cell lymphoma feel better and stay healthy longer.

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment175 (estimated)
SponsorPeking University People's Hospital
Academic / other
Drugs / interventionsRituximab, Polatuzumab, chemotherapy, cyclophosphamide, prednisone
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedMay 3, 2023
Main results expectedApril 27, 2025
Study endsApril 27, 2027
Registry record updatedMay 6, 2023
Trial IDNCT05831865 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include previously untreated patients with CD20-positive DLBCL and an IPI score of three or higher.

Probably not a fit

Patients with lower-risk DLBCL or those who have received prior treatment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the efficacy and safety of autologous stem cell transplantation (ASCT) as a frontline therapy for patients with high-risk diffuse large B-cell lymphoma (DLBCL), defined by an International Prognostic Index (IPI) score of three or higher. Participants will receive standard R-CHOP chemotherapy followed by ASCT, with their responses monitored through imaging techniques such as CT and PET-CT. The study will track patients for up to two years to determine the treatment's effectiveness and safety profile.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with high-risk DLBCL.

How similar studies have gone: While the use of ASCT in this context is controversial, previous studies have suggested potential benefits, indicating that this approach is being explored further.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Peking University People's Hospital
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

  • Principal investigator: Jin Lu, M.D. — Peking University People's Hospital
  • Study coordinator: Xuelin Dou, M.D.
  • Email: dxldw@163.com
  • Phone: 010-88326999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.