An Open, Single Center, Non-randomized, Single Arm Clinical Study of Evaluating the Efficacy of S… (NCT05822050) | Clinical Trial Compass
UnknownPhase 2/3
An Open, Single Center, Non-randomized, Single Arm Clinical Study of Evaluating the Efficacy of Selinexor in the Maintenance Treatment of PTCL
China20 participantsStarted 2023-06-01
Plain-language summary
To evaluate the efficacy and safety of Selinexor maintenance therapy in PTCL patients who achieved complete response from frontline treatment, and to analyze the relationship between gene mutation in PTCL and disease prognosis and clinical features by using Next-generation sequencing (NGS) detection.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Patients fully understand the study, voluntarily participate and sign the informed consent (ICF);
* Age range from 18 to 85 years old (including upper and lower limits);
* ECOG (Eastern Cooperative Oncology Group) score 0 \~ 2;
* PTCL confirmed by histopathology falls into one of the following subtypes according to the WHO classification standard revised in 2016:1) Peripheral T-cell lymphoma non-specific type (PTCL-NOS) 2) vascular immunoblastic T-cell lymphoma (AITL) 3) ALK+ systemic anaplastic large T-cell lymphoma (ALK+ALCL) 4) Alk-systemic anaplastic large T-cell lymphoma (ALK-AlCl) 5) extranasal NK/ T-cell lymphoma (NK/TCL)6) Other subtypes of PTCL that the researchers considered suitable for inclusion.
* Subjects achieved complete remission by radiographic assessment at mid-stage.
* Subjects must provide a written pathological/histological diagnosis report during the screening period and must agree to provide tumor tissue sections or tumor/lymph node tissue samples for central laboratory testing.
* Expected survival is at least 12 weeks.
* Patients must meet the following requirements for laboratory tests at screening time and have not received cell growth factor, platelet, or granulocyte infusion within 7 days prior to screening hematological evaluation.1) Neutrophil absolute value ≥1.5×109/L in subjects without bone marrow involvement and ≥1.0×109/L in subjects with bone marrow involvement;2) Hemoglobin ≥90g/L in subjects without bone marrow inv…
What they're measuring
1
Progression Free Survival rate of 1 year (1y PFS rate)
Timeframe: 1 year from the start of selinexor treatment