| NCT ID | NCT05831865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | Diffuse Large B Cell Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 175 participants |
| Start Date | 2023-05-03 |
| Primary Completion | 2025-04-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 175 participants in total. It began in 2023-05-03 with a primary completion date of 2025-04-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jin Lu, M.D.
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT05831865 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05831865 currently recruiting?
Yes, NCT05831865 is actively recruiting participants. Contact the research team at dxldw@163.com for enrollment information.
Where is the NCT05831865 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05831865 clinical trial?
NCT05831865 is sponsored by Peking University People's Hospital. The principal investigator is Jin Lu, M.D. at Peking University People's Hospital. The trial plans to enroll 175 participants.