Phase II Study of Golidocitinib and Benmelstobart in Pati... | NCT06733051

Studies
Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)

NCT06733051

Sponsor

Sun Yat-sen University

Status

Recruiting

Last Update Posted

Feb 10, 2025Actual

Enrollment

47Estimated

Phase

Phase 2

Conditions

Natural Killer T-cell Lymphoma

Interventions

Golidocitinib
Benmelstobart

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 27, 2024Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Dec 8, 2024

First Submission Date that Met QC Criteria

Dec 12, 2024

First Posted Date

Dec 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2025

Last Update Posted Date

Feb 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Golidocitinib Drug: Benmelstobart

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Golidocitinib	Drug	150 mg, administered once daily from Day 1 to Day 21 (D1-D21)	Golidocitinib and Benmelstobart Combination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate(ORR)	The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.	2 years

Secondary Outcomes

Measure	Description	Time Frame
Complete Response(CR)	Defined as the proportion of patients who achieve complete remission as the best response	2 years
Duration of Response(DOR)	To investigate the preliminary anti-tumor efficacy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Qingqing Cai, MD. PhD.	Contact	0086-20-87342823		caiqq@sysucc.org.cn

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tongren Hospital	Recruiting	Beijing	Beijing Municipality	100730	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided