Combination treatment for relapsed or refractory natural killer T-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination treatment using golidocitinib and benmelstobart in patients with relapsed or refractory extranodal natural killer/T cell lymphoma. It is a prospective, single-arm, multicenter phase II trial that aims to determine how well these medications work together in this specific patient population. Participants must have previously failed at least one line of asparaginase-based therapy and meet other eligibility criteria. The study will assess treatment outcomes based on measurable lesions and overall patient health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed consent.
2. Pathologically confirmed extranodal natural killer/T cell lymphoma (ENKTL).
3. Age ≥18, no gender limitation.
4. Treatment failure to at least one line of asparaginase-based therapy.
5. Eastern Cooperative Oncology Group performance status of 0-2
6. Expected survival ≥ 3 months.
7. At least one measurable lesion that meets Lugano 2014 criteria.
8. Sufficient organ function.

Exclusion Criteria:

1. Invasive NK-cell leukemia or NKTCL that has progressed to leukemia.
2. Accompanied by hemophagocytic lymphohistiocytosis.
3. NKTCL with central nervous system invasion.
4. Previously treated with JAK inhibitors.
5. The patients have contraindications to any drug in the combined treatment.
6. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
7. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
8. Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
9. Mentally ill persons or persons unable to obtain informed consent. The investigators think that the patient is not suitable for the study.

Where it's running

• Beijing Tongren Hospital
  Beijing, Beijing Municipality, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Qingqing Cai, MD. PhD.
• Email: caiqq@sysucc.org.cn
• Phone: 0086-20-87342823

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.