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NCT Number: NCT06733051

Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R 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.

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Key information

Conditions

Natural Killer T-cell Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tongren Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

golidocitinib

Drug

150 mg, administered once daily from Day 1 to Day 21 (D1-D21)

Benmelstobart

Drug

1200 mg, administered on Day 1 (D1) of every cycle

Primary outcomes

  1. 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.

Secondary outcomes

  1. Complete Response(CR)

    Time frame: 2 years

    Defined as the proportion of patients who achieve complete remission as the best response

  2. Duration of Response(DOR)

    Time frame: Up to 4 years

    To investigate the preliminary anti-tumor efficacy

  3. Progression-free survival(PFS)

    Time frame: Up to 4 years

    To investigate the preliminary anti-tumor efficacy

  4. Overall survival(OS)

    Time frame: Up to 4 years

    To investigate the preliminary anti-tumor efficacy

  5. 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.

    To identify the incidence of AE, SAE, and irAE.

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqing Cai, MD. PhD.

CONTACT

[email protected]

0086-20-87342823

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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)

Acronym: JACKPOT50

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Dec 13, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.