NCT05831865|Recruiting
Frontline of ASCT in High-risk DLBCL
Essential
The Efficacy and Safety of Autologous Stem Cell Transplantation (ASCT) in Frontline Therapy of Patients With High-Risk Diffuse Large B-Cell Lymphoma
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Essential
The Efficacy and Safety of Autologous Stem Cell Transplantation (ASCT) in Frontline Therapy of Patients With High-Risk Diffuse Large B-Cell Lymphoma
Sponsor study identifier
observational
175
1 country
1
Study Start
May 3, 2023
Actual (reported)Primary Completion
April 27, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 27, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 27, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 16, 2023
Actual (reported)April 26, 2023
Actual (reported)May 3, 2023
Actual (reported)April 27, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 27, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Progression-free survival (PFS)
From the start of treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier.
2 years
Percentage of Participants With complete response (CR) or complete metabolic response (CMR)
2 years
Percentage of Participants With partial response (PR) or partial metabolic response (PMR)
2 years
Overall survival (OS)
2 years
During the interim evaluation, patients achieving complete response (CR) as determined by computed tomography (CT), or complete metabolic response (CMR) as determined by positron emission tomography-computed tomography (PET-CT), will be followed up for up to two years after completing the R-CHOP regimen followed by ASCT.
During the interim evaluation, patients achieving partial response (PR) as determined by CT, or partial metabolic response (PMR) as determined by PET-CT, and who are willing to receive Pola-R-CHP as the following treatment regimen followed by ASCT with Pola-BEAM as conditioning regimen, will also be followed up for up to two years.
Patients diagnosed with DLBCL and an IPI score equal to or greater than three and consent to receive the standard R-CHOP regimen followed by ASCT. During the interim evaluation, patients achieving CR or CMR, will be followed up for up to two years after completing the R-CHOP regimen followed by ASCT. Patients achieving PR or PMR and who are willing to receive Pola-R-CHP as the following treatment regimen followed by ASCT, will also be followed up for up to two years. Patients achieving less than a PR or PMR response will be excluded from the study.
Peking University People's Hospital
Beijing, Beijing Municipality, 010, China
Jin Lu, M.D.
Peking University People's Hospital
First Submitted
April 16, 2023
First Posted
April 26, 2023
Study Start
May 3, 2023
Actual (reported)Primary Completion
April 27, 2025
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 27, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 6, 2023
Record last verified: 2023-05
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