Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06530550

PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-12

51

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Linperlisib or Duvelisib, with an expected overall response rate of 60% for PI3K inhibitor treatment.

CONDITIONS

Official Title

PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with relapsed or refractory indolent T/NK-cell lymphomas
  • Adults aged 18 years or older
  • Able to take oral PI3K inhibitor treatment
  • No prior use of PI3K inhibitors
  • Tumors that have not progressed after treatment over a specific period, including complete response, partial response, or stable disease
Not Eligible

You will not qualify if you...

  • Previous use of any PI3K inhibitors
  • Conditions that interfere with drug absorption or compliance, such as dysphagia or chronic gastrointestinal diseases
  • Unable to stop medications that prolong QT interval during the study
  • Active infections requiring treatment (viral, bacterial, fungal)
  • Hepatitis B or C infection or active hepatitis
  • History of immunodeficiency, HIV, organ or stem cell transplantation
  • Autologous stem cell transplant within 90 days before study treatment
  • Severe or uncontrolled cardiovascular disease
  • Serious diseases that threaten safety or study completion (e.g., uncontrolled hypertension, diabetes, thyroid disease)
  • Pregnant or breastfeeding women, or positive pregnancy test at baseline
  • Other malignancies diagnosed or treated within past 5 years
  • Any condition deemed unsuitable by the investigator for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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Research Team

S

Shuhua Yi, Doctor

CONTACT

L

Lugui Qiu, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas | DecenTrialz