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

NCT06530550 | Recruiting Phase 2 DMC

• 1 other identifier: IIT2024026
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lymphoma, T-Cell; NK-LGL Leukemia; T-LGL Leukemia

Keywords

Indolent T/NK-cell lymphomas; PI3K inhibitor

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  complete remission rate+ partial remission rate

  up to 5 years

Secondary Outcomes (7)

• The safety of PI3K inhibitors

  up to 5 years

• Complete remession rate

  up to 5 years

• Duration of remission

  up to 5 years

• Time to response

  up to 5 years

• Progression-free survival

  up to 5 years

Study Arms (1)

PI3K inhibitor

EXPERIMENTAL

Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally

Drug: PI3K inhibitor

Interventions

PI3K inhibitor DRUG

Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first

PI3K inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).

You may not qualify if:

• Here is the translated text:
• Subjects who have previously used any PI3K inhibitors;
• Clinical conditions of dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
• Unable to discontinue medications that may prolong the QT interval (such as antiarrhythmic drugs) during the study period;
• Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
• HBV or HCV infection (defined as HBsAg and/or HBcAb positive with HBV DNA copy number ≥ upper limit of normal reference value) or acute or chronic active hepatitis C (HCV) antibody positive;
• History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or history of allogeneic bone marrow or hematopoietic stem cell transplantation;
• Received autologous hematopoietic stem cell transplantation within 90 days before the first dose of study treatment;
• Presence of severe or uncontrolled cardiovascular disease;
• Presence of severe concomitant diseases that endanger patient safety or are deemed by the investigator to affect the completion of the study (e.g., uncontrolled hypertension, diabetes, thyroid disease);
• Pregnant or breastfeeding female patients, or baseline pregnancy test positive for women of childbearing potential;
• Diagnosed or treated for other malignancies within the past 5 years;
• Any other condition that the investigator deems unsuitable for participation in the study.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell; Leukemia, Large Granular Lymphocytic

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, T-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Study Officials

• Shuhua Yi, Doctor

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuhua Yi, Doctor

CONTACT

86-22-23909106; yishuhua@ihcams.ac.cn

Lugui Qiu, Doctor

CONTACT

86-22-23909172; qiulg@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: July 31, 2024
• Study Start: August 10, 2024
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): July 10, 2028
• Last Updated: August 12, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)