This study is conducted to evaluate the efficacy and safety of linperlisib combined with CHOP regimen followed by autologous hematopoietic stem cell transplantation and linperlisib monotherapy maintenance for newly diagnosed nTFHL patients.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed nTFHL classified by WHO-HAEM5, including nodal TFH cell lymphoma, angioimmunoblastic-type, nodal TFH cell lymphoma, follicular-type, Nodal TFH cell lymphoma, NOS
✓. Patients planning to receive autologous hematopoietic stem cell transplantation;
✓. No previous systemic treatment before enrollment.;
✓. There is at least one measurable lesion: the longest diameter (LDi) of the lymph node lesion is greater than 1.5 cm, or the LDi of one extra lymph node lesion is greater than 1 cm (according to the 2014 Lugano classification);
✓. Age range from 18 to 65 years old, regardless of gender;
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)≤2;
✓. Expected survival time≥12 weeks;
✓. Adequate bone marrow and organ functions; For female participants of childbearing period, a negative urine or serum pregnancy test should be performed with 1 week prior to receiving first dose of investigational drug (day 1 of cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required.WOCBP subjects and male subjects whose partners are WOCBP should agree to use effective contraception from the time of signing the ICF until 6 months after the last dose of study drug.
Exclusion criteria
✕. Known allergy to the active ingredients or excipients of linperlisib and CHOP regimens.
✕. Patients with factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
✕. The subject had any active, known, or suspected autoimmune disease. Subjects who are in a stable state and do not require systemic immunosuppressive therapy are admitted;
✕. Known history of interstitial pneumonia;
✕. Current or previous history of other malignancies within 2 years prior to study enrollment.Radically treated basal cell carcinoma of the skin, papillary thyroid carcinoma, squamous skin carcinoma, carcinoma in situ of the breast and carcinoma in situ of the cervix, excepted
✕. Received systemic antitumor therapy, including chemotherapy, immunotherapy, and biotherapy (tumor vaccines, cytokines, or growth factors used to control cancer) within 28 days prior to study enrollment.
✕. Received autologous or allogeneic hematopoietic stem cell transplantation;