New Diagnosed Angioimmunoblastic T-Cell LymphomaPhase 2NCT07168317
Tislelizumab , Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of New Diagnosed AITL
A Phase 2 study testing tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone in people with New Diagnosed Angioimmunoblastic T-Cell Lymphoma, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
Angioimmunoblastic T-cell lymphoma (AITL) is a rare and aggressive lymphoma. At present, the treatment of new diagnosed AITL has limited efficacy and a high recurrence rate. The study seeks to explore the possibility of improving the efficacy of immunotherapy and chemotherapy and epigenetically regulated drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- New Diagnosed Angioimmunoblastic T-Cell Lymphoma
- What is being tested?
- tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Aug 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of AITL according to WHO classification in 2016, and pathological diagnosis of AITL according to WHO classification in 2016, and at least one evaluable or measurable lesion meeting Lugano2014 criteria: lymph node lesion, detectable lymph node length>1.5cm; non-lymph node lesion, detectable extra-nodal lesion length>1.0cm;
- Never received systemic or local treatment including chemotherapy before;
- Age ≥18 years old, male or female, ECOGPS≤3 points;
- Life expectancy exceeds 3 months;
- Follow-up conditions. Patients understand the characteristics of the disease and voluntarily join the study protocol for treatment and follow-up.
Who cannot join
- Subjects who meet any of the following criteria are not eligible for inclusion in this study:
- Patients with abnormal liver and kidney function, specifically serum direct bilirubin, serum indirect bilirubin and/or alanine aminotransferase, aspartate aminotransferase and serum creatinine>2 times normal values, unless abnormal liver and kidney function is considered to be related to lymphoma;
- Bone marrow failure, specifically defined as absolute neutrophil count (ANC)<1.5*10^9/L or platelets <75*10^9/L or Hb<90g/L, unless changes in hemogram are considered to be associated with lymphoma infiltration of the bone marrow;
- Patients who have previously received local or systemic anti-tumor treatment;
- Chronic heart failure with cardiac function class III or IV; or left ventricular ejection fraction <50%; or patients with the following cardiac diseases within 6 months: acute coronary syndrome; acute heart failure (Class III or IV of cardiac function class); patients with a history of clinically significant QT prolongation (>450 ms for men,>470 ms for women), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, symptomatic coronary heart disease requiring medical treatment;
- AIDS, syphilis, active B (HBV DNA>1*10^4 copies/ml) and hepatitis C;
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- Patients with other malignancies that are not effectively controlled; or with other hematological disorders (e.g. hemophilia, myelofibrosis, etc.), the investigator considers that the patient is not suitable for enrollment;
- History of autoimmune disease, receiving immunosuppressive therapy before enrollment, immunosuppressive dose>10 mg/day or oral prednisone for more than 2 weeks;
- Clinically uncontrolled active infection (including bacterial, fungal or viral infections), and drug therapy is ineffective;
- Patients with uncontrolled hemophagocytic syndrome;
- Patients who have received secondary surgery or above within 3 weeks before treatment;
- Patients who have participated in clinical trials of other drugs within 30 days before enrollment or are participating in clinical trials of other new drugs;
- Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
- Known allergies to investigational drug components;
- The investigator considers that the enrollment is not suitable.
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 Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Wei Sang Doctor, 136452076, sw1981726@126.com
About this study
Official title: Efficacy and Safety of Tislelizumab in Combination With Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of New Diagnosed AITL: a Multicenter, Single-arm, Prospective Clinical Study
Angioimmunoblastic T-cell lymphoma (AITL) is a rare and aggressive lymphoma. At present, the treatment of new diagnosed AITL has limited efficacy and a high recurrence rate. The study seeks to explore the possibility of improving the efficacy of immunotherapy and chemotherapy and epigenetically regulated drugs.
- Being tested
- tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisoneDrug
tislelizumab: 200mg on d1 every 3 weeks; chidamide: 20mg twice a week at least 3 days apart; cyclophosphamide: 750mg/m2 on Day 1 of each cycle, every 4 weeks; mitoxantrone liposomes: 20mg/m2 on Day 1, every 4 weeks; prednisone: 100mg/day on Day 1 to Day 5 of each course, every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Patients with new diagnosed angioblastic T cell lymphoma | Experimental | Patients with new diagnosed angioblastic T cell lymphoma Receives: Drug: tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure
To evaluate the Objective Response Rate (Complete response+Partial response) of tirelizumab in combination with cyclophosphamide, mitoxantrone liposomes, sidaraniline, and prednisone in subjects with relapsed/refractory angioimmunoblastic T-cell lymphoma
Measured: Time forecasting: 24 months
Secondary outcomes (3)
24-month Overall Survival Rate in relapsed/refractory AITL
Proportion of patients alive at 24 months after initiation of tirelizumab combination therapy
Measured: From first dose until death from any cause (assessed at 24 months)
24-month Progression-free Survival Rate in relapsed/refractory AITL
Proportion of patients without disease progression at 24 months per Lugano 2014 criteria
Measured: From first dose until first documented progression or death (assessed at 24 months)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Time forecasting: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Aug 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Diagnosed Angioimmunoblastic T-Cell LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168317
- Sponsor's protocol ID
- XYFY2025-KL332-01
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tislelizumab in Combination With Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of New Diagnosed AITL: a Multicenter, Single-arm, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07168317
- Acronym / sponsor ID
- XYFY2025-KL332-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 11 Sep 2025 (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.
Angioimmunoblastic T-cell lymphoma (AITL) is a rare and aggressive lymphoma. At present, the treatment of new diagnosed AITL has limited efficacy and a high recurrence rate. The study seeks to explore the possibility of improving the efficacy of immunotherapy and chemotherapy and epigenetically regulated drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with new diagnosed angioblastic T cell lymphoma | Experimental | Drug: tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisonePatients with new diagnosed angioblastic T cell lymphoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathological diagnosis of AITL according to WHO classification in 2016, and pathological diagnosis of AITL according to WHO classification in 2016, and at least one evaluable or measurable lesion meeting Lugano2014 criteria: lymph node lesion, detectable lymph node length>1.5cm; non-lymph node lesion, detectable extra-nodal lesion length>1.0cm;
Key exclusion criteria (15 listed)
- Subjects who meet any of the following criteria are not eligible for inclusion in this study:
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 |
|---|---|---|
| tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisonetislelizumab: 200mg on d1 every 3 weeks; chidamide: 20mg twice a week at least 3 days apart; cyclophosphamide: 750mg/m2 on Day 1 of each cycle, every 4 weeks; mitoxantrone liposomes: 20mg/m2 on Day 1, every 4 weeks; prednisone: 100mg/day on Day 1 to Day 5 of each course, every 4 weeks. | Drug | Patients with new diagnosed angioblastic T cell lymphoma |
Primary outcome
Outcome Measure
Time frame: Time forecasting: 24 months
To evaluate the Objective Response Rate (Complete response+Partial response) of tirelizumab in combination with cyclophosphamide, mitoxantrone liposomes, sidaraniline, and prednisone in subjects with relapsed/refractory angioimmunoblastic T-cell lymphoma
3 secondary outcomes
24-month Overall Survival Rate in relapsed/refractory AITL
Time frame: From first dose until death from any cause (assessed at 24 months)
24-month Progression-free Survival Rate in relapsed/refractory AITL
Time frame: From first dose until first documented progression or death (assessed at 24 months)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Time forecasting: 24 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 11 Sep 2025.
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 2 study testing tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone in people with New Diagnosed Angioimmunoblastic T-Cell Lymphoma, run by The Affiliated Hospital of Xuzhou Medical 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 5 inclusion and 15 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 11 Sep 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Wei Sang Doctor (136452076, sw1981726@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Measure (time frame: Time forecasting: 24 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 11 Sep 2025.