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

NCT ID: NCT06609304

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

axi-cel treatment

Group Type: EXPERIMENTAL

Axicabtagene Ciloleucel

Intervention Type: BIOLOGICAL

Axicabtagene Ciloleucel at 2.0×10\^6/Kg

Interventions

Axicabtagene Ciloleucel

Axicabtagene Ciloleucel at 2.0×10\^6/Kg

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Understand and voluntarily sign the informed consent form;

2. 18-70 years of age (inclusive);

3. Previously untreated CD19-positive large B-cell lymphoma;

4. Anticipated survival ≥12 weeks;

5. Adequate bone marrow reserve prior to apheresis

6. Appropriate organ function:

7. Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1; 8. Absence of CNS lymphoma;

9. Negative blood/urine pregnancy test in women of childbearing age.

Exclusion Criteria

1. History of allergy to any of the components of the cell product;

2. History of stem cell transplantation;

3. History of organ transplantation;

4. Presence of active infections;

5. Current or history of central nervous system disorders;

6. Previous treatment with other modified T-cell therapy;

7. Previous treatment with anti-CD19/CD3 or other anti-CD19 therapies;

8. Malignancies other than those indicated for this trial;

9. History of any prior systemic immune checkpoint therapy;

10. History of short-acting cell growth factors or haematopoietic agonists/stimulants ;

11. History of a live vaccine within 3 months prior to screening;.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

Mingzhi Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Zhengzhou University, Department of Oncology

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhang, PhD

Role: CONTACT

fcczhangxd@zzu.edu.cn

86-0371-66279567

Facility Contacts

Xudong Zhang, PhD

Role: primary

fcczhangxd@zzu.edu.cn

86-0371-66279567

Other Identifiers

TA2024-252

Identifier Type: -

Identifier Source: org_study_id