Extranodal Natural Killer T Cell LymphomaPhase 1/2NCT05464433

Tislelizumab Combined with Mitoxantrone Hydrochloride Liposome in Extranodal Natural Killer/T Cell Lymphoma

A Phase 1/2 study testing Tislelizumab combined with Liposomal mitoxantrone hydrochloride and Maintenance of tislelizumab in people with Extranodal Natural Killer T Cell Lymphoma, run by Sun Yat-sen University at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy in combination with tislelizumab and mitoxantrone hydrochloride liposome combination treatment in patients with relapsed or refractory Extranodal Natural Killer/T Cell Lymphoma（NKTCL） Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Extranodal Natural Killer T Cell Lymphoma
What is being tested?: Tislelizumab combined with Liposomal mitoxantrone hydrochloride and Maintenance of tislelizumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 6 sitesChina
Study dates: 23 Jun 2022to 30 Nov 2025
Phase: Phase 1/2
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Histologically confirmed diagnosis of Extranodal Natural Killer/T Cell Lymphoma（NKTCL）
2. Subjects fully understand and voluntarily participate in this study and sign informed consent
3. Age ≥18, ≤75 years, no gender limitation
4. Relapsed or refractory NKTCL that has failed to be treated with a asparaginase-based chemotherapy or chemoradiotherapy regimen. Refractory definition: I) the efficacy of chemotherapy with asparaginase-containing regimen did not reach CR; Or II) disease progression within 6 months of the last regimen containing asparaginase; Definition of recurrence: lymphoma that recurred after a complete response (CR) was achieved with initial chemotherapy
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2；
6. Expected survival ≥ 3 months;

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7. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma: measurable lesion: Positron emission tomography / computed tomography (PET/CT) or CT and/or MRI, intranode lesions with long diameter >1.5cm, short diameter >1.0cm, or exnode lesions with long diameter > 1.0 cm; PET CT examination of the lesion showing increased uptake in lymph nodes or extranodal areas (higher than liver) and imaging features consistent with lymphoma can be evaluated.
8. Without hemophagocytic syndrome; If patients diagnosed hemophagocytic syndrome are treated with anti-hemophagocytic syndrome drugs, the general physical condition of the patients will be evaluated by the investigator to determine whether the patients can be included in the group.
9. The following required baseline laboratory data:
White blood cell，WBC≥3.0×109/L(Bone marrow invasive patient≥2.0×109/L),Absolute neutrophil count，ANC ≥1.5×109/L, （Bone marrow invasive patient≥1.0×109/L) Platelet count (PLT) ≥75×109/L, （Bone marrow invasive patient≥50×109/L) ，Hemoglobin (HB)≥ 80g/L, No granulocyte growth factor, platelet, or red blood cell transfusions were received within 14 days prior to examination.
Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) （The liver invasion≤3.0×ULN）Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN , Serum creatinine ，Scr ≤1.5×ULN（The liver invasion≤5.0×ULN）
Renal function：creatinine, Cr≤1.5×ULN
Coagulation function： International Normalized Ratio，INR≤1.5 ×ULN； Prothrombin Time (PT)、Activated Partial Thromboplastin Time (APTT)≤1.5×ULN（Unless the patient is receiving anticoagulant therapy and PT and APTT are within the expected range of anticoagulant therapy at screening time）；
Thyroid stimulating hormone (TSH) or free thyroid hormone (FT4) or free triiodothyronine (FT3) were within 10% of normal value (note: abnormal TSH caused by non-autoimmune causes can be included in the group);

Who cannot join

1. The subject had previously received mitoxantrone liposomes or the total cumulative dose of mitoxantrone is more than 160 mg/m2 and the total cumulative dose of doxorubicin is more than 360 mg/m2
2. A history of other malignant tumors within the past 5 years; Or other tumors (except basal cell carcinoma of the skin)
3. Invasive NK cell leukemia; Or central nervous system invasion;
4. Participated in clinical trials of other drugs within 4 weeks prior to study commencement;
5. Patients had received antitumor therapy 4 weeks prior to study initiation;
6. Patients who received allogeneic hematopoietic stem cell transplantation within 3 years prior to study drug administration (patients who received allogeneic hematopoietic stem cell transplantation more than 3 years prior to study drug administration and who do not currently have graft-versus-host reaction can be included); Received autologous hematopoietic stem cell 8 transplantation within 100 days prior to administration of the study drug;

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7. People with a history of Human Immunodeficiency Virus infection and acquired Immunodeficiency syndrome;
8. Patients with chronic active hepatitis B or active hepatitis C. Background Hepatitis B Surface Antigen (HBsAg) or Hepatitis B core Antibody (HBcAb) or Hepatitis C Virus (HCV) antibody, Must be further tested for Hepatitis B Virus (HBV) DNA (no more than 1000 copies /mL or 2 00 IU/mL) and HCV RNA (no more than the lower limit of the assay). Active hepatitis B or C infection requiring treatment should be excluded. Hepatitis B virus carriers, stable hepatitis B after drug treatment (DNA should not be more than 1000 copies /mL or 200 IU/mL and cured hepatitis C patients can be included;
9. Subjects who required systemic glucocorticoid therapy or other immunosuppressant therapy for a condition within 14 days prior to initiation of treatment [subjects were allowed to use topical, ocular, intra-articular, intranasal, and inhaled glucocorticoid therapy (with very low systemic absorption); It is permissible to use glucocorticoids for short-term (≤ 7 days) prophylactic treatment (e.g., contrast agent allergy) or for the treatment of non-autoimmune diseases (e.g., delayed hypersensitivity from contact allergens)
10. With activity, and over the past two years, need systemic treatment of autoimmune diseases (hormone replacement therapy is not considered a systemic treatment, such as type 1 diabetes, by accepting thyroid hormone replacement therapy for hypothyroidism, only need to accept the physiological doses of sugar cortical hormone replacement therapy adrenocortical function is low or pituitary function in patients with low); Patients with autoimmune diseases who have not required systemic treatment within the past two years can be enrolled;
11. Heart function and disease meet one of the following conditions:
Long QTc syndrome or QTc interval > 480 MS;
Complete left bundle branch block, grade II or III atrioventricular block;
Serious and uncontrolled arrhythmias requiring drug treatment;
New York Heart Association grade ≥ III;
Cardiac ejection fraction (LVEF)< 50%;
A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.、
12. Patients who underwent major surgery within 28 days before enrollment; Chronic unhealed wounds or broken bones;
13. Live attenuated vaccines (excluding influenza vaccines) received within 4 weeks prior to enrollment or planned during the study period;
14. Pregnant and lactating women and subjects of childbearing age who do not want to use contraception;
15. Mentally ill persons or persons unable to obtain informed consent;
16. Active infection, except for tumor-associated symptom B fever.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

Beijing Tongren Hospital, Capital Medical University
Beijing
Peking Union Medical College Hospital
Beijing
The Second Hospital of Dalian Medical University
Dalian
Sun Yat-Sen University Cancer Center
Guangzhou
The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University
Guangzhou
Jiangxi Cancer Hospital
Nanchang

Other trials in China

About this study

Official title: Open-Label, PhaseIb/Ⅱ Study of Tislelizumab and Mitoxantrone Hydrochloride Liposome Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma（ALLIANCE-022）

Read the detailed description

This is a prospective, open-label, single arm, multicenter clinical study to explore the maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride when combined with tislelizumab in patients with relapsed or refractory Extranodal Natural Killer/T Cell Lymphoma（NKTCL）. Liposomal mitoxantrone hydrochloride will be given on day 1 at two different doses (16 mg/m2, 20 mg/m2) and be combined with tislelizumab. The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned. An dose expansion study of mitoxanquinone hydrochloride liposome at recommended phaseII dose (RP2D) dose level combined with tirelizumab was conducted to explore the efficacy and safety tolerance of the combined regimen. After 6 cycles of induction therapy, if the outcome was assessed as complete remission (CR)/partial remission (PR)/Stable disease (SD), continued maintenance therapy with tirelizumab.

Conditions: Extranodal Natural Killer T Cell Lymphoma
Being tested: Tislelizumab combined with Liposomal mitoxantrone hydrochloride, Maintenance of tislelizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tislelizumab combined with Liposomal mitoxantrone hydrochlorideDrug
Drug: liposomal mitoxantrone hydrochloride, tislelizumab Drug: Liposomal mitoxantrone hydrochloride (16 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.
Drug: tislelizumab(200 mg) will be taken orally on day 1 of each 28-day cycle.
Maintenance of tislelizumabDrug
Drug: tislelizumab(200 mg) will be taken orally on day 1 of each 21-day cycle

Study groups in NCT05464433
Study group	Role	What they receive
liposomal mitoxantrone hydrochloride	Experimental	Patients with recurrent and refractory Extranodal Natural Killer/T Cell Lymphoma（NKTCL）will receive sequentially higher doses of liposomal mitoxantrone hydrochloride in combination with tislelizumab for 6 cycles (planned) (28 days per cycle). The initial dose of liposomal mitoxantrone hydrochloride is 16 mg/m2. Receives: Drug: Tislelizumab combined with Liposomal mitoxantrone hydrochloride; Drug: Maintenance of tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose limited toxicities (DLTs)
To identify the DLT
Measured: Cycle 1 (28 days)
Recommended Phase II Dose（RP2D）
To identify the RP2D
Measured: Cycle 1 (28 days)
Complete response rate (CR)
To investigate the preliminary antitumor efficacy
Measured: Up to 24 weeks

Secondary outcomes (4)

Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
To identify the incidence of AE and SAE
Measured: Up to 24 weeks
Overall response rate (ORR)
To investigate the preliminary antitumor efficacy
Measured: Up to 24 weeks
Disease control rate（DCR）
To investigate the preliminary antitumor efficacy
Measured: Up to 24 weeks
Progression-free survival（PFS）
To investigate the preliminary antitumor efficacy
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jun 202230 Nov 2025

First posted19 Jul 2022
Study start23 Jun 2022
Primary completion30 Apr 2025 (estimated)
Study completion30 Nov 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Extranodal Natural Killer T Cell LymphomaStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 46 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05464433
Sponsor's protocol ID: B2022-300
Status last verified: Mar 2025
First submitted: 4 Jul 2022
Last updated: 13 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Extranodal Natural Killer T Cell Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label, PhaseIb/Ⅱ Study of Tislelizumab and Mitoxantrone Hydrochloride Liposome Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma（ALLIANCE-022）
ClinicalTrials.gov ID: NCT05464433
Acronym / sponsor ID: B2022-300
Conditions: Extranodal Natural Killer T Cell Lymphoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 46 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 23 Jun 2022 (actual)
Primary completion: 30 Apr 2025 (estimated)
Study completion: 30 Nov 2025 (estimated)
First posted: 19 Jul 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
liposomal mitoxantrone hydrochloride	Experimental	Drug: Tislelizumab combined with Liposomal mitoxantrone hydrochloride, Drug: Maintenance of tislelizumabPatients with recurrent and refractory Extranodal Natural Killer/T Cell Lymphoma（NKTCL）will receive sequentially higher doses of liposomal mitoxantrone hydrochloride in combination with tislelizumab for 6 cycles (planned) (28 days per cycle). The initial dose of liposomal mitoxantrone hydrochloride is 16 mg/m2.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

1. Histologically confirmed diagnosis of Extranodal Natural Killer/T Cell Lymphoma（NKTCL）
2. Subjects fully understand and voluntarily participate in this study and sign informed consent
3. Age ≥18, ≤75 years, no gender limitation
4. Relapsed or refractory NKTCL that has failed to be treated with a asparaginase-based chemotherapy or chemoradiotherapy regimen. Refractory definition: I) the efficacy of chemotherapy with asparaginase-containing regimen did not reach CR; Or II) disease progression within 6 months of the last regimen containing asparaginase; Definition of recurrence: lymphoma that recurred after a complete response (CR) was achieved with initial chemotherapy
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2；

Key exclusion criteria (22 listed)

1. The subject had previously received mitoxantrone liposomes or the total cumulative dose of mitoxantrone is more than 160 mg/m2 and the total cumulative dose of doxorubicin is more than 360 mg/m2
2. A history of other malignant tumors within the past 5 years; Or other tumors (except basal cell carcinoma of the skin)
3. Invasive NK cell leukemia; Or central nervous system invasion;
4. Participated in clinical trials of other drugs within 4 weeks prior to study commencement;
5. Patients had received antitumor therapy 4 weeks prior to study initiation;

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 combined with Liposomal mitoxantrone hydrochlorideDrug: liposomal mitoxantrone hydrochloride, tislelizumab Drug: Liposomal mitoxantrone hydrochloride (16 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle. Drug: tislelizumab(200 mg) will be taken orally on day 1 of each 28-day cycle.	Drug	liposomal mitoxantrone hydrochloride
Maintenance of tislelizumabDrug: tislelizumab(200 mg) will be taken orally on day 1 of each 21-day cycle	Drug	liposomal mitoxantrone hydrochloride

Primary outcome

Dose limited toxicities (DLTs)
Time frame: Cycle 1 (28 days)
To identify the DLT
Recommended Phase II Dose（RP2D）
Time frame: Cycle 1 (28 days)
To identify the RP2D
Complete response rate (CR)
Time frame: Up to 24 weeks
To investigate the preliminary antitumor efficacy

4 secondary outcomes

Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
Time frame: Up to 24 weeks
Overall response rate (ORR)
Time frame: Up to 24 weeks
Disease control rate（DCR）
Time frame: Up to 24 weeks
Progression-free survival（PFS）
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 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 13 Mar 2025.

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Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limited toxicities (DLTs) (time frame: Cycle 1 (28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05464433.

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 13 Mar 2025.