Frontline of ASCT in High-risk DLBCL

Diffuse Large B Cell Lymphoma Clinical Trial

— Essential  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831865
• Other study ID #: 2023PHB119
• Status: Recruiting
• Start date: May 3, 2023
• Est. completion date: April 27, 2027

Study information

• Verified date: May 2023
• Source: Peking University People's Hospital
• Contact: Xuelin Dou, M.D.
• Phone: 010-88326999
• Email: dxldw[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: April 27, 2027
• Est. primary completion date: April 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

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