Frontline of ASCT in High-risk DLBCL (Essential)

May 3, 2023 updated by: JinLu, Peking University People's Hospital

The Efficacy and Safety of Autologous Stem Cell Transplantation (ASCT) in Frontline Therapy of Patients With High-Risk Diffuse Large B-Cell Lymphoma

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

There is evidence to suggest that chemotherapy followed by ASCT may be more effective than standard chemotherapy alone as a frontline treatment for high-risk DLBCL patients. However, the use of ASCT as frontline therapy for DLBCL remains controversial due to concerns over the potential toxicities of the procedure, as well as questions about which patients would benefit most from this approach.

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.

Study Type

Observational

Enrollment (Anticipated)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xuelin Dou, M.D.
  • Phone Number: 7003 010-88326999
  • Email: dxldw@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 010
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Xuelin Dou, M.D.
          • Phone Number: 7003 +86-010-82816999
          • Email: dxldw@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 2 years
From the start of treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 2 years
From the start of treatment until death from any cause
2 years
Percentage of Participants With complete response (CR) or complete metabolic response (CMR)
Time Frame: 2 years
Assessed by Lugano Response Criteria
2 years
Percentage of Participants With partial response (PR) or partial metabolic response (PMR)
Time Frame: 2 years
Assessed by Lugano Response Criteria
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Jin Lu, M.D., Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Anticipated)

April 27, 2025

Study Completion (Anticipated)

April 27, 2027

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

April 16, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023PHB119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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