Frontline of ASCT in High-risk DLBCL

Trial Title: Frontline of ASCT in High-risk DLBCL

NCT ID: NCT05831865

Condition: Diffuse Large B Cell Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse

Conditions: Keywords:
autologous stem cell transplantation
international prognostic index

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Peking University People's Hospital

Address:
City: Beijing
Zip: 010
Country: China

Status: Recruiting

Contact:
Last name: Xuelin Dou, M.D.

Phone: +86-010-82816999

Phone ext: 7003
Email: dxldw@163.com

Start date: May 3, 2023

Completion date: April 27, 2027

Lead sponsor:
Agency: Peking University People's Hospital
Agency class: Other

Collaborator:
Agency: Peking University Cancer Hospital & Institute
Agency class: Other

Source: Peking University People's Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05831865