Frontline of ASCT in High-risk DLBCL

Last updated: May 3, 2023
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Lymphoma, B-cell

Treatment

N/A

Clinical Study ID

NCT05831865
2023PHB119
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Previously untreated participants with cluster of differentiation 20 (CD20)-positiveDLBCL, 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-richlarge B-cell lymphoma; Epstein-Barr virus-positive DLBCL, NOS; anaplastic lymphomakinase (ALK)-positive large B-cell lymphoma; human herpesvirus-8 (HHV8)-positiveDLBCL, NOS; High-grade B-cell lymphoma with MYC and B-cell lymphoma 2 (BCL2) and/orB-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

Exclusion Criteria:

  • Contraindication to any of the individual components of CHOP, including prior receiptof anthracyclines
  • Participants with central nervous system (CNS) lymphoma (primary or secondaryinvolvement)
  • History of other malignancy that could affect compliance with the protocol orinterpretation of results

Study Design

Total Participants: 175
Study Start date:
May 03, 2023
Estimated Completion Date:
April 27, 2027

Study 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.

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 010
    China

    Active - Recruiting

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