Natural Killer T-cell LymphomaPhase 2JACKPOT50NCT06733051
Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)
A Phase 2 study testing Golidocitinib and Benmelstobart in people with Natural Killer T-cell Lymphoma, run by Sun Yat-sen University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Natural Killer T-cell Lymphoma
- What is being tested?
- Golidocitinib and Benmelstobart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesChina
- Study dates
- 27 Jan 2024to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 subjects 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Liang Wang, M.D. Ph.D, 15001108693, wangliangtrhos@126.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Qingqing Cai, M.D. Ph.D, 0086-20-87342823, caiqq@sysucc.org.cn
About this study
Official title: 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)
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.
- Conditions
- Natural Killer T-cell Lymphoma
- Being tested
- Golidocitinib, Benmelstobart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolidocitinibDrug
150 mg, administered once daily from Day 1 to Day 21 (D1-D21)
BenmelstobartDrug
1200 mg, administered on Day 1 (D1) of every cycle
| Study group | Role | What they receive |
|---|---|---|
| Golidocitinib and Benmelstobart Combination | Experimental | 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. Receives: Drug: Golidocitinib; Drug: Benmelstobart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
Measured: 2 years
Secondary outcomes (5)
Complete Response(CR)
Defined as the proportion of patients who achieve complete remission as the best response
Measured: 2 years
Duration of Response(DOR)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 4 years
Progression-free survival(PFS)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 4 years
Overall survival(OS)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 4 years
Incidence and severity of adverse events (AE) , Serious adverse event (SAE) and immune-related adverse event (irAE)
To identify the incidence of AE, SAE, and irAE.
Measured: Through study completion, up tp 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start27 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Natural Killer T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733051
- Sponsor's protocol ID
- B2024-736-01
- Acronym
- JACKPOT50
- Status last verified
- Feb 2025
- First submitted
- 8 Dec 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06733051
- Acronym / sponsor ID
- JACKPOT50 / B2024-736-01
- Conditions
- Natural Killer T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golidocitinib and Benmelstobart Combination | Experimental | Drug: Golidocitinib, Drug: BenmelstobartPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Golidocitinib150 mg, administered once daily from Day 1 to Day 21 (D1-D21) | Drug | Golidocitinib and Benmelstobart Combination |
| Benmelstobart1200 mg, administered on Day 1 (D1) of every cycle | Drug | Golidocitinib and Benmelstobart Combination |
Primary outcome
Objective response rate(ORR)
Time frame: 2 years
The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
5 secondary outcomes
Complete Response(CR)
Time frame: 2 years
Duration of Response(DOR)
Time frame: Up to 4 years
Progression-free survival(PFS)
Time frame: Up to 4 years
Overall survival(OS)
Time frame: Up to 4 years
Incidence and severity of adverse events (AE) , Serious adverse event (SAE) and immune-related adverse event (irAE)
Time frame: Through study completion, up tp 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Natural Killer T-cell Lymphoma
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Not yet recruitingPhase 1
BLinatumomab and iNKT in Relapsed B-Cell ALL
B-Cell ALL, ALL (Acute B-Lymphoblastic Leukemia)
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Active, not recruitingPhase 2
Study of Pembrolizumab in Patients With Early-Stage NK/T-cell Lymphoma, Nasal Type
NK/T-Cell Lymphoma of Nasal Cavity (Diagnosis), NK/T-Cell Lymphoma of Nasopharynx (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Golidocitinib and Benmelstobart in people with Natural Killer T-cell Lymphoma, run by Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingqing Cai, MD. PhD. (0086-20-87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.