Linperlisib Combined With EZH2 Inhibitor in Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a type of cancer that affects certain white blood cells known as T-cells. The study is testing a combination of two drugs: linperlisib and SHR2554, to see if they are safe and how well they work together against this type of lymphoma. It is important to note that this trial is currently not recruiting participants.

To be eligible for this study, participants need to be at least 18 years old and have been diagnosed with PTCL confirmed by a doctor. They should have already tried at least one previous treatment for their cancer. Additionally, they need to have a measurable tumor that the researchers can evaluate. Participants will need to be able to complete all study procedures and follow the guidelines set by the researchers. If someone is interested in joining the trial, they will receive detailed information and must provide their consent to participate. This study aims to provide new options for patients battling this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years old, male or female;
• • 2. Pathologically confirmed PTCL, including systemic anaplastic large cell lymphoma (ALCL), peripheral T cell lymphoma non-specific type (PTCL NOS), lymph node T-follicular helper cell lymphoma (nTFHL) \[including nTFHL angioimmunoblastic type (NTFHL-AI), nTFHL follicular type (NTFHL-F) and nTFHL non-specific name (NTFHL-NOS)\], enteropathy-associated T-cell lymphoma and hepato-splenic T-cell lymphoma;
• • 3. Have received at least one previous systemic therapy, ALCL patients must have received CD30-targeted therapy; Patients were allowed to have received hematopoietic stem cell transplantation;
• • 4. There must be at least one evaluable lesion/measurable lesion that meets the 2014 version of Lugano lymphoma evaluation criteria \[Evaluable lesion
• • 5. ECOG PS 0-2;
• 6. Adequate organ function:
• • 7. Expected survival of at least 3 months;
• • 8. Fertile male and female subjects are willing to use effective contraceptive measures throughout the study period and for six months after the last dose.
• • 9. Volunteer to participate in clinical studies and sign informed consent, willing to follow and able to complete all trial procedures.
• Exclusion Criteria:
• If a patient has any of the following conditions should not be included in this study:
• • 1. Had been treated with PI3K inhibitor or EZH2 inhibitor or EZH1/2 inhibitor before enrollment;
• • 2. Primary cutaneous T-cell lymphoma;
• • 3. History of other primary aggressive malignancies that are not in remission or in remission for no more than 3 years;
• • 4. Involvement of the central nervous system (meninges or brain parenchyma);
• • 5. People with a known allergy to any of the drugs in the study
• • 6. Participated in other drug clinical trials within 4 weeks before the study began;
• • 7. Pregnant or lactating women;
• • 8. Active infected persons, except tumor-related B symptom fever;
• 9. Diseases and medical history:
• • 1. have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
• • 2. have a history of psychotropic substance abuse and can not quit or have mental disorders;
• • 3. Subjects with any severe and/or uncontrolled medical condition;
• • 10. A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• • 11. Other situations deemed unsuitable for inclusion in the study by the researcher.