Actively Recruiting
A Single-arm, Open-label, Phase II Study of Golidocitinib and Benmelstobart Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (ENKTL) (JACKPOT50)
Led by Sun Yat-sen University · Updated on 2025-02-10
47
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of golidocitinib and benmelstobart for patients with relapsed or refractory extranodal natural killer/T cell lymphoma (ENKTL). This phase II clinical trial aims to assess both the effectiveness and safety of this combination treatment in adults who have previously undergone asparaginase-based therapy without success. Participants will receive golidocitinib at a dose of 150 mg daily from Day 1 to Day 21 of each 3-week cycle, along with a single 1200 mg dose of benmelstobart on Day 1 of each cycle. Treatment continues every three weeks for up to 24 months or until disease progression, unacceptable side effects, or other reasons for stopping. During the study, participants will be monitored for tumor response, including the objective response rate over two years, and outcomes such as complete response, duration of response, progression-free survival, and overall survival up to four years. Safety assessments will track adverse events throughout the study. Participants will undergo regular evaluations to measure treatment effects and manage any side effects, with the total participation lasting up to two years or more depending on treatment continuation.
CONDITIONS
Brief Title
Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects fully understand and voluntarily participate in this study and sign informed consent.
- Pathologically confirmed extranodal natural killer/T cell lymphoma (ENKTL).
- Age 18 years or older, 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 of at least 3 months.
- At least one measurable lesion that meets Lugano 2014 criteria.
- Sufficient organ function.
You will not qualify if you...
- 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.
- Contraindications to any drug in the combined treatment.
- Infection with human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
- Inability to swallow tablets, presence of malabsorption syndrome, or other gastrointestinal disease affecting drug absorption.
- Pregnant or lactating women and subjects of childbearing age not willing to use contraception.
- Mentally ill persons or persons unable to give informed consent, or deemed unsuitable by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months or until disease progression, unacceptable toxicities, or other reasons lead to discontinuation.
Participants receive golidocitinib daily and benmelstobart every 3 weeks as a combination treatment for their lymphoma.
Visits every 3 weeks corresponding to treatment cycles
Trial Site Locations
Total: 2 locations
1
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Q
Qingqing Cai, MD. PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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