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New treatment option for Natural Killer T-cell Lymphoma
Official title Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)
ClinicalTrials.gov ID: NCT06733051
What this study is testing
What is Golidocitinib?
Golidocitinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for natural killer 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
- This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of golidocitinib and benmelstobart combination treatment in patients with relapsed or refractory extranodal natural killer/T cell lymphoma.
- 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
- people fully understand and voluntarily participate in this study and sign informed consent.
- Pathologically confirmed extranodal natural killer/T cell lymphoma (ENKTL).
- Age ≥18, no gender limitation.
- Treatment failure to at least one line of asparaginase-based therapy.
- Eastern Cooperative Oncology Group performance status of 0-2
You likely can't join if
- Invasive NK-cell leukemia or NKTCL that has progressed to leukemia.
- Accompanied by hemophagocytic lymphohistiocytosis.
- NKTCL with central nervous system invasion.
- Previously treated with JAK inhibitors.
- The patients have contraindications to any drug in the combined treatment.
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
See the full eligibility criteria
- people fully understand and voluntarily participate in this study and sign informed consent.
- Pathologically confirmed extranodal natural killer/T cell lymphoma (ENKTL).
- Age ≥18, no gender limitation.
- Treatment failure to at least one line of asparaginase-based therapy.
- Eastern Cooperative Oncology Group performance status of 0-2
- Expected survival ≥ 3 months.
- At least one measurable lesion that meets Lugano 2014 criteria.
- Sufficient organ function.
- Invasive NK-cell leukemia or NKTCL that has progressed to leukemia.
- Accompanied by hemophagocytic lymphohistiocytosis.
- NKTCL with central nervous system invasion.
- Previously treated with JAK inhibitors.
- The patients have contraindications to any drug in the combined treatment.
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
- Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
- Pregnant and lactating women and people of childbearing age who do not want to use contraception.
- Mentally ill persons or persons unable to obtain informed consent. The investigators think that the patient is not suitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, 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, Beijing Municipality, China; Guangzhou, Guangdong, 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.