Extranodal NK T Cell LymphomaPhase 1/2NCT07525466
Combination of Mitoxantrone Liposome and Etoposide, Dexamethasone, Pegaspargase and Golidocitinib (MEPL-G) in the Treatment of NK/T-cell Lymphoma Associated Hemophagocytic Lymphohistiocytosis (NKTCL-HLH)
A Phase 1/2 study testing Mitoxantrone liposome, Etoposide and Pegaspargase (PEG) Asparaginase in people with Extranodal NK T Cell Lymphoma and Hemophagocytic Lymphohistiocytosis (HLH), run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Extranodal NK/T-cell lymphoma (NKTCL) is an aggressive EBV-associated lymphoma with poor prognosis, highly prevalent in China. Early-stage NKTCL achieves favorable long-term survival, while advanced disease shows dismal outcomes with no standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extranodal NK T Cell Lymphoma, Hemophagocytic Lymphohistiocytosis (HLH)
- What is being tested?
- Mitoxantrone liposome, Etoposide and Pegaspargase (PEG) Asparaginase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Sep 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed extranodal NK/T-cell lymphoma.
- Meeting the HLH-2004 diagnostic criteria (≥ 5 criteria).
- Age ≥ 18 years, regardless of gender.
- Negative HIV antigen or antibody.
- Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac echocardiography.
- No active visceral bleeding (e.g., gastrointestinal, pulmonary, cerebral).
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- No uncontrolled infection (e.g., pulmonary infection, intestinal infection).
- Negative HCV antibody; or positive HCV antibody with negative HCV RNA.
- Negative HBsAg and negative HBcAb. If either is positive, peripheral blood HBV DNA load must be < 1×10³ copies/mL to be eligible.
- Signed written informed consent and ability to understand and comply with all study requirements.
Who cannot join
- New York Heart Association (NYHA) cardiac function class ≥ II;
- Female patients who are pregnant or breastfeeding;
- Known hypersensitivity to any of the study drugs;
- Presence of other concurrent malignancies (except non-melanoma skin cancer);
- Concurrent central nervous system lymphoma infiltration;
- Severe psychiatric disorders or inability to comply with follow-up;
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- Severe renal dysfunction (glomerular filtration rate < 15 mL/min);
- Severe liver cirrhosis (MELD score > 20);
- History of acute or chronic pancreatitis;
- Simultaneous participation in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jia Cong, M.D. contact
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, 100730
Liang Wang, M.D., +861058266633, wangliangtrhos@126.com
Jia Cong, M.D., congjia21@163.com
About this study
Official title: Combination of Mitoxantrone Liposome and Etoposide, Dexamethasone, Pegaspargase and Golidocitinib (MEPL-G) in the Treatment of NK/T-cell Lymphoma Associated Hemophagocytic Lymphohistiocytosis (NKTCL-HLH): a Prospective, Multi-center, Single Arm, Phase Ib/II Clinical Trial
Extranodal NK/T-cell lymphoma (NKTCL) is an aggressive EBV-associated lymphoma with poor prognosis, highly prevalent in China. Early-stage NKTCL achieves favorable long-term survival, while advanced disease shows dismal outcomes with no standard therapy. Notably, 10%-20% of patients develop secondary hemophagocytic lymphohistiocytosis (NKTCL-HLH), a life-threatening complication with median survival <2 months and mortality over 90%. Current treatments fail to simultaneously control lymphoma and hyperinflammation, with poor tolerance and high resistance.
The JAK/STAT pathway drives EBV-induced inflammation and tumor progression. Golidocitinib, a selective JAK1 inhibitor, demonstrates potent anti-NKTCL activity and rapid inflammation control. Liposomal mitoxantrone offers targeted efficacy with lower toxicity, while etoposide, methylprednisolone, and pegaspargase provide synergistic anti-tumor and anti-HLH effects.
This study proposes the novel MEPL-G regimen (liposomal mitoxantrone, etoposide, methylprednisolone, pegaspargase, golidocitinib) for NKTCL-HLH. By targeting both HLH and NKTCL, this combination aims to achieve rapid disease control, improve tolerance, and prolong survival, addressing the unmet critical clinical need for this high-risk population.
Read the detailed description
Extranodal NK/T-cell lymphoma (NKTCL) is an aggressive Epstein-Barr virus (EBV)-associated non-Hodgkin lymphoma with particularly high incidence in Asia, especially in southern China where it accounts for 10%-15% of all malignant lymphomas. Early-stage NKTCL can achieve an 80% long-term survival rate with radiotherapy combined with pegaspargase-based chemotherapy. However, advanced and relapsed/refractory NKTCL carries a dismal prognosis, with long-term survival below 40%. A severe complication is hemophagocytic lymphohistiocytosis (HLH), which develops in 10%-20% of patients and leads to an extremely aggressive clinical course, with median survival less than 2 months and 6-month overall survival of only 23%.
Pathogenically, EBV infection induces abnormal immune activation through the JAK/STAT and NF-κB pathways, triggering a cytokine storm characterized by elevated IFN-γ, TNF-α, IL-6, and IL-10. This immune dysregulation, combined with impaired cytotoxic function, drives both lymphomagenesis and HLH progression. Current treatments remain unsatisfactory. Traditional HLH-directed regimens fail to control underlying lymphoma, while conventional lymphoma chemotherapy shows limited efficacy and poor tolerance due to multi-drug resistance and organ dysfunction.
Recently, targeted agents have emerged as promising strategies. Golidocitinib, a highly selective JAK1 inhibitor, effectively blocks JAK1-STAT3 signaling, suppresses EBV-driven tumor growth, and mitigates cytokine storms. It has demonstrated encouraging anti-tumor activity in relapsed/refractory NKTCL. Meanwhile, liposomal mitoxantrone improves tumor targeting and reduces cardiotoxicity, with objective response rates of 50%-60% in NKTCL. Etoposide, methylprednisolone, and pegaspargase further provide synergistic anti-lymphoma and anti-inflammatory effects.
Our research group has accumulated extensive experience in NKTCL and NKTCL-HLH, validating effective combination regimens and supporting the rationale of combining anti-lymphoma and anti-HLH strategies. Therefore, this study designed the innovative MEPL-G regimen (liposomal mitoxantrone, etoposide, methylprednisolone, pegaspargase, golidocitinib) for NKTCL-HLH patients. This regimen aims to rapidly control HLH, eradicate lymphoma, improve safety and tolerance, and ultimately prolong survival, addressing the urgent unmet medical need for this high-risk population.
- Being tested
- Mitoxantrone liposome, Etoposide, Pegaspargase (PEG) Asparaginase, methylprednisolone, golidocitinib
- Keywords
- extranodal NK/T-cell lymphoma, hemophagocytic lymphohistiocytosis, Mitoxantrone Liposome, Golidocitinib, JAK1
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone liposomeDrug
In the Phase Ib part, 3 patients will be enrolled at the starting dose of liposomal mitoxantrone: 18 mg/m²/d on day 1, every 3 weeks (q3w). If no DLT occurs, the recommended phase 2 dose (RP2D) will be 18 mg/m²/d on day 1 q3w. If DLT occurs, the dose will be de-escalated sequentially (18→16→14→12 mg/m²/d on day 1 q3w).
EtoposideDrug
100mg/m²/d，d1、d8，q3w
Pegaspargase (PEG) AsparaginaseDrug
2000IU/m²/d，d5，q3w
15mg/kg/d，d1-3 7.5mg/kg/d，d4-7
1mg/kg/d d8-14 10mg/d，d15-21
golidocitinibDrug
150mg/d，d1-d21，q3w
| Study group | Role | What they receive |
|---|---|---|
| MEPL-G group | Experimental | All enrolled patients may initiate induction therapy with the MEPL-G regimen after completing baseline imaging and laboratory examinations.
The detailed administration is as follows:
Doses of etoposide, golidocitinib, pegaspargase, and methylprednisolone are fixed. The optimal dose of liposomal mitoxantrone will be determined based on dose-limiting toxicity (DLT). In the Phase Ib part, 3 patients will be enrolled at the starting dose of liposomal mitoxantrone: 18 mg/m²/d on day 1, every 3 weeks (q3w). If no DLT occurs, the recommended phase 2 dose (RP2D) will be 18 mg/m²/d on day 1 q3w. If DLT occurs, the dose will be de-escalated sequentially. One cycle is 3 weeks, for a total of 6 cycles.
Patients achieving CR or PR after 2 cycles may be referred for allogeneic hematopoietic stem cell transplantation.
Patients with CR or PR after 2 cycles who are ineligible for transplantation may continue MEPL-G for a total of 6 cycles, followed by maintenance therapy with golidocitinib monotherapy Receives: Drug: Mitoxantrone liposome; Drug: Etoposide; Drug: Pegaspargase (PEG) Asparaginase; Drug: methylprednisolone; Drug: golidocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month overall survival (OS) rate
OS was defined from the date of initiation of MEPL-G to the date fo death.
Measured: From the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G
Secondary outcomes (4)
6-month progression free survival (PFS) rate
PFS was defined from the date of initiation of MEPL-G to the date of confirmed disease progression or death of any reason
Measured: From the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G
overall response rate (ORR)
Overall response rate means sum of complete response rate and partial response rate
Measured: from the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G.
complete response (CR) rate
CR was defined as complete response evaluated using PET-CT scan
Measured: from the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
measured using CTCAE version 5.0
Measured: from the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIANG WANG, Beijing Tongren Hospital
- Investigators
- Liang Wang, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525466
- Sponsor's protocol ID
- TRhos-NKTCL-HLH
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Mitoxantrone Liposome and Etoposide, Dexamethasone, Pegaspargase and Golidocitinib (MEPL-G) in the Treatment of NK/T-cell Lymphoma Associated Hemophagocytic Lymphohistiocytosis (NKTCL-HLH): a Prospective, Multi-center, Single Arm, Phase Ib/II Clinical Trial
- ClinicalTrials.gov ID
- NCT07525466
- Acronym / sponsor ID
- TRhos-NKTCL-HLH
- Keywords
- extranodal NK/T-cell lymphoma, hemophagocytic lymphohistiocytosis, Mitoxantrone Liposome, Golidocitinib, JAK1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 13 Apr 2026 (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.
Extranodal NK/T-cell lymphoma (NKTCL) is an aggressive EBV-associated lymphoma with poor prognosis, highly prevalent in China. Early-stage NKTCL achieves favorable long-term survival, while advanced disease shows dismal outcomes with no standard therapy. Notably, 10%-20% of patients develop secondary hemophagocytic lymphohistiocytosis (NKTCL-HLH), a life-threatening complication with median survival <2 months and mortality over 90%. Current treatments fail to simultaneously control lymphoma and hyperinflammation, with poor tolerance and high resistance.
The JAK/STAT pathway drives EBV-induced inflammation and tumor progression. Golidocitinib, a selective JAK1 inhibitor, demonstrates potent anti-NKTCL activity and rapid inflammation control. Liposomal mitoxantrone offers targeted efficacy with lower toxicity, while etoposide, methylprednisolone, and pegaspargase provide synergistic anti-tumor and anti-HLH effects.
This study proposes the novel MEPL-G regimen (liposomal mitoxantrone, etoposide, methylprednisolone, pegaspargase, golidocitinib) for NKTCL-HLH. By targeting both HLH and NKTCL, this combination aims to achieve rapid disease control, improve tolerance, and prolong survival, addressing the unmet critical clinical need for this high-risk population.
Detailed description
Extranodal NK/T-cell lymphoma (NKTCL) is an aggressive Epstein-Barr virus (EBV)-associated non-Hodgkin lymphoma with particularly high incidence in Asia, especially in southern China where it accounts for 10%-15% of all malignant lymphomas. Early-stage NKTCL can achieve an 80% long-term survival rate with radiotherapy combined with pegaspargase-based chemotherapy. However, advanced and relapsed/refractory NKTCL carries a dismal prognosis, with long-term survival below 40%. A severe complication is hemophagocytic lymphohistiocytosis (HLH), which develops in 10%-20% of patients and leads to an extremely aggressive clinical course, with median survival less than 2 months and 6-month overall survival of only 23%.
Pathogenically, EBV infection induces abnormal immune activation through the JAK/STAT and NF-κB pathways, triggering a cytokine storm characterized by elevated IFN-γ, TNF-α, IL-6, and IL-10. This immune dysregulation, combined with impaired cytotoxic function, drives both lymphomagenesis and HLH progression. Current treatments remain unsatisfactory. Traditional HLH-directed regimens fail to control underlying lymphoma, while conventional lymphoma chemotherapy shows limited efficacy and poor tolerance due to multi-drug resistance and organ dysfunction.
Recently, targeted agents have emerged as promising strategies. Golidocitinib, a highly selective JAK1 inhibitor, effectively blocks JAK1-STAT3 signaling, suppresses EBV-driven tumor growth, and mitigates cytokine storms. It has demonstrated encouraging anti-tumor activity in relapsed/refractory NKTCL. Meanwhile, liposomal mitoxantrone improves tumor targeting and reduces cardiotoxicity, with objective response rates of 50%-60% in NKTCL. Etoposide, methylprednisolone, and pegaspargase further provide synergistic anti-lymphoma and anti-inflammatory effects.
Our research group has accumulated extensive experience in NKTCL and NKTCL-HLH, validating effective combination regimens and supporting the rationale of combining anti-lymphoma and anti-HLH strategies. Therefore, this study designed the innovative MEPL-G regimen (liposomal mitoxantrone, etoposide, methylprednisolone, pegaspargase, golidocitinib) for NKTCL-HLH patients. This regimen aims to rapidly control HLH, eradicate lymphoma, improve safety and tolerance, and ultimately prolong survival, addressing the urgent unmet medical need for this high-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEPL-G group | Experimental | Drug: Mitoxantrone liposome, Drug: Etoposide, Drug: Pegaspargase (PEG) Asparaginase, Drug: methylprednisolone, Drug: golidocitinibAll enrolled patients may initiate induction therapy with the MEPL-G regimen after completing baseline imaging and laboratory examinations. The detailed administration is as follows: Doses of etoposide, golidocitinib, pegaspargase, and methylprednisolone are fixed. The optimal dose of liposomal mitoxantrone will be determined based on dose-limiting toxicity (DLT). In the Phase Ib part, 3 patients will be enrolled at the starting dose of liposomal mitoxantrone: 18 mg/m²/d on day 1, every 3 weeks (q3w). If no DLT occurs, the recommended phase 2 dose (RP2D) will be 18 mg/m²/d on day 1 q3w. If DLT occurs, the dose will be de-escalated sequentially. One cycle is 3 weeks, for a total of 6 cycles. Patients achieving CR or PR after 2 cycles may be referred for allogeneic hematopoietic stem cell transplantation. Patients with CR or PR after 2 cycles who are ineligible for transplantation may continue MEPL-G for a total of 6 cycles, followed by maintenance therapy with golidocitinib monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed extranodal NK/T-cell lymphoma.
- Meeting the HLH-2004 diagnostic criteria (≥ 5 criteria).
- Age ≥ 18 years, regardless of gender.
- Negative HIV antigen or antibody.
- Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac echocardiography.
Key exclusion criteria (10 listed)
- New York Heart Association (NYHA) cardiac function class ≥ II;
- Female patients who are pregnant or breastfeeding;
- Known hypersensitivity to any of the study drugs;
- Presence of other concurrent malignancies (except non-melanoma skin cancer);
- Concurrent central nervous system lymphoma infiltration;
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 |
|---|---|---|
| Mitoxantrone liposomeIn the Phase Ib part, 3 patients will be enrolled at the starting dose of liposomal mitoxantrone: 18 mg/m²/d on day 1, every 3 weeks (q3w). If no DLT occurs, the recommended phase 2 dose (RP2D) will be 18 mg/m²/d on day 1 q3w. If DLT occurs, the dose will be de-escalated sequentially (18→16→14→12 mg/m²/d on day 1 q3w). | Drug | MEPL-G group |
| Etoposide100mg/m²/d，d1、d8，q3w | Drug | MEPL-G group |
| Pegaspargase (PEG) Asparaginase2000IU/m²/d，d5，q3w | Drug | MEPL-G group |
| methylprednisolone15mg/kg/d，d1-3 7.5mg/kg/d，d4-7 1mg/kg/d d8-14 10mg/d，d15-21 | Drug | MEPL-G group |
| golidocitinib150mg/d，d1-d21，q3w | Drug | MEPL-G group |
Primary outcome
6-month overall survival (OS) rate
Time frame: From the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G
OS was defined from the date of initiation of MEPL-G to the date fo death.
4 secondary outcomes
6-month progression free survival (PFS) rate
Time frame: From the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G
overall response rate (ORR)
Time frame: from the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G.
complete response (CR) rate
Time frame: from the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: from the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G
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 Apr 2026.
- 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.
Jia Cong, M.D. contact
Liang Wang principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mitoxantrone liposome, Etoposide and Pegaspargase (PEG) Asparaginase in people with Extranodal NK T Cell Lymphoma and Hemophagocytic Lymphohistiocytosis (HLH), run by Beijing Tongren Hospital 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 10 inclusion and 10 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 13 Apr 2026. 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 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?
Contact Liang Wang, M.D. (+861058266633, wangliangtrhos@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month overall survival (OS) rate (time frame: From the date of initiation of MEPL-G as of 6 months after initiation of MEPL-G). 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 13 Apr 2026.