Lymphoma, B-CellPhase 4axi-celNCT06609304
Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
A Phase 4 study testing Axicabtagene Ciloleucel in people with Lymphoma, B-Cell, run by Zhengzhou University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- Axicabtagene Ciloleucel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to 31 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign the informed consent form;
- 18-70 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;
- 9. Negative blood/urine pregnancy test in women of childbearing age.
Who cannot join
- 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;
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- 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;.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University, Department of Oncology
Zhengzhou, Henan, 450052
Xudong Zhang, PhD, 86-0371-66279567, fcczhangxd@zzu.edu.cn
About this study
Official title: Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
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
- Being tested
- Axicabtagene Ciloleucel
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axicabtagene CiloleucelBiological
Axicabtagene Ciloleucel at 2.0×10^6/Kg
| Study group | Role | What they receive |
|---|---|---|
| axi-cel treatment | Experimental | Not described Receives: Biological: Axicabtagene Ciloleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
one year PFS
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start30 Sep 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingzhi Zhang, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609304
- Sponsor's protocol ID
- TA2024-252
- Acronym
- axi-cel
- Status last verified
- Jul 2024
- First submitted
- 28 Aug 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06609304
- Acronym / sponsor ID
- axi-cel / TA2024-252
- Conditions
- Lymphoma, B-Cell
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| axi-cel treatment | Experimental | Biological: Axicabtagene Ciloleucel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Understand and voluntarily sign the informed consent form;
- 18-70 years of age (inclusive);
- Previously untreated CD19-positive large B-cell lymphoma;
- Anticipated survival ≥12 weeks;
- Adequate bone marrow reserve prior to apheresis
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axicabtagene CiloleucelAxicabtagene Ciloleucel at 2.0×10^6/Kg | Biological | axi-cel treatment |
Primary outcome
one year PFS
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Axicabtagene Ciloleucel in people with Lymphoma, B-Cell, run by Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhang, PhD (86-0371-66279567, fcczhangxd@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one year PFS (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.