BridgeMD
New treatment option for Extranodal NK T Cell Lymphoma
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)
ClinicalTrials.gov ID: NCT07525466
What this study is testing
What is Mitoxantrone liposome?
Mitoxantrone liposome is an investigational medicine, being studied as a potential treatment for extranodal nk t cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.