NCT05831865Recruiting
Frontline of ASCT in High-risk DLBCL
The Efficacy and Safety of Autologous Stem Cell Transplantation (ASCT) in Frontline Therapy of Patients With High-Risk Diffuse Large B-Cell Lymphoma
Source: ClinicalTrials.gov · Last updated 6 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 175 (estimated)
- First submitted
- 16 Apr 2023
- Start date
- 3 May 2023
- Primary completion date
- 27 Apr 2025
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT05831865
What you commit to
- Study type: Observational
- Planned participants: 175
- From 3 May 2023 to the primary completion date, 27 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
Other illness
- History of other malignancy that could affect compliance with the protocol or interpretation of results
Other
- Participants with central nervous system (CNS) lymphoma (primary or secondary involvement)
Who the study is looking for
- 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)
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.