peripheral T-cell lymphoma (PTCL) is a group of non-Hodgkin's lymphoma (NHL) with highly heterogeneous morphological changes from post-thymus mature T cells or NK cells. According to the latest NCCN guidelines classification, PTCL mainly includes eight subtypes: PTCL non-special finger type (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic lymphoma kinase-positive anaplastic large cell lymphoma (ALK+ALCL), anaplastic lymphoma kinase-negative anaplastic large cell lymphoma (ALK-ALCL), enteropathy-related T-cell lymphoma , monomorphic epithelial intestinal T-cell lymphoma, lymph node peripheral T-cell lymphoma with Tfh phenotype, follicular T-cell lymphoma.
The incidence rate of this group of diseases in China is relatively high, accounting for about 25% to 30% of NHL, which is significantly higher than that of European and American countries (10% to 15%). Most of PTCL have strong aggressiveness, high malignancy, and poor prognosis .
In recent years, with the development of science and technology, many new anti-tumor drugs, such as different types of enzyme inhibitors, monoclonal antibodies, immunomodulators, immune checkpoint inhibitors, epigenetic drugs, etc., has been proven to be effective against peripheral T-cell lymphomas .
Free clinical project
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PI3Kα/δ inhibitor TQ-B3525
Test Title: TQ-B3525 for the treatment of relapsed/refractory peripheral T cell lymphoma (PTCL) single-arm, open, multicenter phase II clinical trial
Test Type: single-arm trial
Indications: relapsed/refractory peripheral T cell lymphoma (third line and above)
Registration number: CTR20202036
Research Center: Beijing, Chongqing, Guiyang, Gansu Lanzhou, Chengde, Hebei, Harbin, Heilongjiang, Zhengzhou, Henan, Jiangsu Nanjing/Nantong , Jiangxi Nanchang, Liaoning Shenyang, Shanghai, Shandong Yantai, Shaanxi Xi'an, Tianjin, Yunnan Kunming
Main entry ranking standards:
1, age: 18-75 years old; ECOG (PS) score: 0~2; estimated survival time ≥3 months.
2. According to the definition of the blood and lymphoid tissue tumor classification (revised in 2017), the histopathologically confirmed peripheral T cell lymphoma (see Appendix VIII for details on recurrence/refractory definition), including the following three subtypes: non-specific peripheral T cell lymphoma (PTCL-NOS); angiovascular immunoblast T cell lymphoma (AITL) (patients with follicular T cell lymphoma and intranodal peripheral T cell lymphoma with follicular assisted T cell phenotype can be enrolled); anaplastic large cell lymphoma (ALCL).
3, previous has received at least a second-line systemic treatment regimen , including a combination chemotherapy regimen containing alkylating agent and anthracyclines, and one of the following drugs: vebutuximab (CD30+ systemic ALCL must have been treated with this drug), cidabenamine, pratriaxa and mitoxantrone liposomes.
4. After CT or MRI, at least one imaging-measurable tumor lesion exists in the two vertical directions (according to the 2014 Lugano standard, the length diameter of the intranode lesion in is >15mm, and the length diameter of the exonode lesion in is >10mm).
5, do not patients with T cell lymphoma accompanied by hemophagocytosis syndrome and patients with other types of T cell lymphoma.
6, do not are known to be patients with transformed or mixed T cell lymphoma.
7, do not lymphoma patients with central nervous system (CNS) invasion.
8. PI3K inhibitor (alpelisib, idelalisib, duvelisib, copanlisib, etc.) or CAR-T cannot participate in .
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