Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma

NCT06609304 | Recruiting Phase 4

• 1 other identifier: TA2024-252
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Axicabtagene Ciloleucel (axi-cel) works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of axi-cel treatment. The main questions it aims to answer are:

• Does axi-cel treatment result in prolonged clinical benefit to patients with high-risk LBCL after first-line treatment?
• What medical problems do participants have when receiving axi-cel treatment? In this investigator-initiated, single-arm clinical trial, participants will:
• Receive atezolizumab treatment at 2.0×10\^6 cells/Kg as a one-time therapy.
• Visit the clinic as instructed for checkups and tests.

Conditions

Lymphoma, B-Cell

Outcome Measures

Primary Outcomes (1)

• one year PFS

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Study Arms (1)

axi-cel treatment

EXPERIMENTAL

Biological: Axicabtagene Ciloleucel

Interventions

Axicabtagene Ciloleucel BIOLOGICAL

Axicabtagene Ciloleucel at 2.0×10\^6/Kg

axi-cel treatment

Eligibility Criteria

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

You may qualify if:

• Understand and voluntarily sign the informed consent form;
• years of age (inclusive);
• Previously untreated CD19-positive large B-cell lymphoma;
• Anticipated survival ≥12 weeks;
• Adequate bone marrow reserve prior to apheresis
• Appropriate organ function:
• Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1; 8. Absence of CNS lymphoma;
• \. Negative blood/urine pregnancy test in women of childbearing age.

You may not qualify if:

• History of allergy to any of the components of the cell product;
• History of stem cell transplantation;
• History of organ transplantation;
• Presence of active infections;
• Current or history of central nervous system disorders;
• Previous treatment with other modified T-cell therapy;
• Previous treatment with anti-CD19/CD3 or other anti-CD19 therapies;
• Malignancies other than those indicated for this trial;
• History of any prior systemic immune checkpoint therapy;
• History of short-acting cell growth factors or haematopoietic agonists/stimulants ;
• History of a live vaccine within 3 months prior to screening;.

Sponsors & Collaborators

• Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University, Department of Oncology

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

axicabtagene ciloleucel

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhang, PhD

CONTACT

86-0371-66279567; fcczhangxd@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 24, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)