Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)
NCT ID: NCT06733051
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
47 participants
INTERVENTIONAL
2024-01-27
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Golidocitinib and Benmelstobart Combination
Patients will receive golidocitinib in combination with benmelstobart every 3 weeks for up to 24 months, until disease progression, unaccpetable toxicities or other reasons lead to discontinuation.
Golidocitinib
150 mg, administered once daily from Day 1 to Day 21 (D1-D21)
Benmelstobart
1200 mg, administered on Day 1 (D1) of every cycle
Interventions
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Golidocitinib
150 mg, administered once daily from Day 1 to Day 21 (D1-D21)
Benmelstobart
1200 mg, administered on Day 1 (D1) of every cycle
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Qingqing Cai
MD. PhD.
Locations
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Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B2024-736-01
Identifier Type: -
Identifier Source: org_study_id
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