ClinicalTrials.gov record NCT07525466

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)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old and older
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase Ib/II, single-arm study tests the MEPL-G drug combination in adults (≥18) with extranodal NK/T‑cell lymphoma complicated by hemophagocytic lymphohistiocytosis (NKTCL‑HLH). The trial includes a phase Ib dose-finding part for liposomal mitoxantrone followed by a phase II expansion at the recommended dose. Main outcomes include 6‑month overall survival, response rates, progression‑free survival, and safety. The study is unmasked and all participants receive the same combination regimen.

What it is studying. The study tests the safety, tolerability, and anti‑disease activity of the MEPL‑G drug combination in NKTCL‑HLH. It will collect data on survival at 6 months, disease responses (complete and partial), progression, and treatment‑emergent adverse events.

What the researchers hope to learn. Scientific goals: determine a recommended phase 2 dose (RP2D) of liposomal mitoxantrone; measure 6‑month overall survival (primary outcome); and assess 6‑month progression‑free survival, overall response rate, complete response rate (by PET‑CT), and the incidence of treatment‑emergent adverse events (CTCAE v5.0).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Mitoxantrone liposome
  • Etoposide
  • Pegaspargase (PEG) Asparaginase
  • methylprednisolone
  • golidocitinib

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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).
  • 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.

Exclusion criteria

  • 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;
  • 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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After baseline imaging and laboratory tests, participants receive the MEPL-G drug combination (mitoxantrone liposome, etoposide, methylprednisolone, pegaspargase, and golidocitinib) in 3-week treatment cycles for up to six cycles. In the Phase Ib part, the liposomal mitoxantrone dose will be adjusted if dose-limiting toxicities occur to define the Phase 2 dose. Patients who have a complete or partial response after two cycles may be referred for allogeneic hematopoietic stem cell transplantation; those who continue on treatment but are not transplant-eligible may complete six cycles and then receive golidocitinib maintenance. The study involves regular safety monitoring, clinical exams, imaging and laboratory tests to check for side effects and response.

How the study is structured. Interventional, single‑group (all participants receive the same treatment), open‑label Phase Ib/II trial. Phase Ib uses dose‑finding for liposomal mitoxantrone (starting at 18 mg/m² on day 1 every 3 weeks with possible de‑escalation) while other drugs have fixed doses. Treatment cycles are 3 weeks; up to six cycles are planned. Participants who achieve complete or partial response after two cycles may be referred for allogeneic stem cell transplant; those not proceeding to transplant may continue to six cycles and then golidocitinib maintenance.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on hemophagocytic lymphohistiocytosis

Clinical trials34 trials listed for hemophagocytic lymphohistiocytosisEvery trial the registry lists for hemophagocytic lymphohistiocytosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hemophagocytic lymphohistiocytosis researchLatest monthly update: September 2026. Includes: Multiple test results. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Apr 1, 2026
Primary completion
Mar 31, 2028 (estimated)
Study completion
Sep 30, 2028 (estimated)
Target enrollment
25 participants (estimated)
Last updated on registry
Apr 13, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Beijing Tongren Hospital
Principal investigator
LIANG WANG, Director of Department of Hematology in Beijing Tongren Hospital
Beijing Tongren Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

standard therapy
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
Histologically confirmed
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
glomerular filtration rate
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
relapsed/refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
overall survival
The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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