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 type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 175 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | Rituximab, Polatuzumab, chemotherapy, cyclophosphamide, prednisone |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | May 3, 2023 |
| Main results expected | April 27, 2025 |
| Study ends | April 27, 2027 |
| Registry record updated | May 6, 2023 |
| Trial ID | NCT05831865 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.
-
Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL
This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.
-
Glofitamab combo vs Rituximab combo with chemo for relapsed/refractory DLBCL
This study tests whether glofitamab with chemotherapy (JS203-GemOx) helps patients with relapsed or refractory DLBCL more than rituximab with chemotherapy.
-
Non-Hodgkin Lymphoma Sample Collection for MRD Testing
This study tests a blood-based and tissue-based approach to see if a molecular residual disease test can detect lingering cancer in adults with aggressive NHL who are starting standard therapy.
-
External beam radiation followed by bispecific antibody therapy for relapsed or refractory DLBCL
This study tests whether giving targeted radiation first, then bispecific antibodies (epcoritamab or glofitamab), is tolerable for adults with relapsed or refractory diffuse large B-cell lymphoma.
-
Chidamide maintenance for MRD-positive double-expressor DLBCL in first remission
This study tests whether giving chidamide as maintenance therapy can help people with double-expressor DLBCL who have complete remission but still have MRD detected in their blood.
-
Cognitive changes in people treated for diffuse large B‑cell lymphoma
This study tests whether adults with newly diagnosed diffuse large B‑cell lymphoma experience cognitive changes during and after standard chemotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.