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Trial Title:
PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
NCT ID:
NCT06530550
Condition:
Lymphoma, T-Cell
NK-LGL Leukemia
T-LGL Leukemia
Conditions: Official terms:
Lymphoma
Leukemia
Lymphoma, T-Cell
Leukemia, Large Granular Lymphocytic
Conditions: Keywords:
Indolent T/NK-cell lymphomas
PI3K inhibitor
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PI3K inhibitor
Description:
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
Arm group label:
PI3K inhibitor
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.
Detailed description:
Plan to enroll 51 patients with relapsed/refractory indolent T/NK-cell lymphomas; they
will receive PI3K inhibitor treatment (including 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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).
Exclusion Criteria:
Here is the translated text:
1. Subjects who have previously used any PI3K inhibitors;
2. Clinical conditions of dysphagia, malabsorption, or other chronic gastrointestinal
diseases that may interfere with compliance and/or absorption of the study drug;
3. Unable to discontinue medications that may prolong the QT interval (such as
antiarrhythmic drugs) during the study period;
4. Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
5. 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;
6. 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;
7. Received autologous hematopoietic stem cell transplantation within 90 days before
the first dose of study treatment;
8. Presence of severe or uncontrolled cardiovascular disease;
9. 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);
10. Pregnant or breastfeeding female patients, or baseline pregnancy test positive for
women of childbearing potential;
11. Diagnosed or treated for other malignancies within the past 5 years;
12. Any other condition that the investigator deems unsuitable for participation in the
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuhua Yi, Dr.
Phone:
86-022-23909106
Email:
yishuhua@ihcams.ac.cn
Contact backup:
Last name:
Lugui Qiu, Dr.
Phone:
86-022-23909286
Email:
qiulg@ihcams.ac.cn
Start date:
August 10, 2024
Completion date:
July 10, 2028
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06530550
