Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
175 participants
OBSERVATIONAL
2023-05-03
2027-04-27
Brief Summary
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Detailed Description
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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 3 points.
Patients diagnosed with DLBCL and an IPI score of equal to or greater than three will be eligible for inclusion in this study, provided they consent to receive the standard R-CHOP (Rituximab, cyclophosphamide, hydroxydaunomycin, oncovin, and prednisone) regimen, followed by ASCT. 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. 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 (Polatuzumab vedotin, rituximab, cyclophosphamide, hydroxydaunomycin, and prednisone) as the following treatment regimen followed by ASCT with Pola-BEAM (Polatuzumab vedotin, carmustine/bendamustine, etoposide, cytarabine and melphalan) as conditioning regimen, 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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DLBCL patients achieving CR or CMR during interim evaluation
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.
No interventions assigned to this group
DLBCL patients achieving PR or PMR during interim evaluation
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Peking University People's Hospital
OTHER
Responsible Party
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JinLu
Professor of Medicine and Hematology, Deputy Director of the Department of Hematology, Principal Investigator
Principal Investigators
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Jin Lu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023PHB119
Identifier Type: -
Identifier Source: org_study_id
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