Frontline of ASCT in High-risk DLBCL

NCT05831865 | Recruiting

• 1 other identifier: 2023PHB119
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

autologous stem cell transplantation; international prognostic index

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 010, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jin Lu, M.D.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuelin Dou, M.D.

CONTACT

010-88326999; dxldw@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Hematology, Deputy Director of the Department of Hematology, Principal Investigator

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: April 26, 2023
• Study Start: May 3, 2023
• Primary Completion: April 27, 2025
• Study Completion (Estimated): April 27, 2027
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)