Evaluating autologous stem cell transplant for high-risk diffuse large B-cell lymphoma
The Efficacy and Safety of Autologous Stem Cell Transplantation (ASCT) in Frontline Therapy of Patients With High-Risk Diffuse Large B-Cell Lymphoma
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 |
|---|---|
| Enrollment | 175 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | Rituximab, Polatuzumab, chemotherapy, cyclophosphamide, prednisone |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05831865 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include previously untreated patients with CD20-positive DLBCL and an IPI score of three or higher.
Not a fit: Patients with lower-risk DLBCL or those who have received prior treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with high-risk DLBCL.
How similar studies have performed: While the use of ASCT in this context is controversial, previous studies have suggested potential benefits, indicating that this approach is being explored further.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.