Chi-GVM Regimen for the Treatment of R/R PTCL

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jan 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL), a type of cancer that affects the lymphatic system. The treatment being evaluated combines four medications: chidamide, gemcitabine, vinorelbine, and Mitoxantrone Hydrochloride Liposome, collectively called the Chi-GVM regimen. The goal is to see if this new combination can help improve patient outcomes, such as how long patients live without the disease worsening and overall survival rates.

To participate in this trial, patients should be between 18 and 75 years old and have been diagnosed with R/R PTCL after receiving at least one prior treatment. They must also have measurable cancer lesions and meet specific health criteria, such as having adequate organ function. During the trial, participants will receive the study medication and be closely monitored for its effects. It’s important to know that this is a research study, so while there may be potential benefits, there are also risks, and not everyone will qualify to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. R/R PTCL confirmed by pathological tissue \[including peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and ALK+ anaplastic large cell lymphoma (ALCL) , ALK-ALCL, monotypic epithelial intestinal T-cell lymphoma (MEITL), etc.\], the diagnostic criteria refer to the 2022 WHO diagnostic criteria; 2. Have had at least one previous systemic treatment \[including chemotherapy, autologous hematopoietic stem cell transplantation (ASCT) ), etc.\] Patients who have no remission or relapse after remission; 3. Sign written informed consent and be able to comply with the visits and related procedures specified in the protocol; 4. Whole-body PET/CT performed 28 days before study enrollment must be At least 1 evaluable or measurable lesion that meets the Lugano2014 criteria: lymph node lesions, measurable lymph nodes must have a long diameter \>1.5 cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter \>1.0 cm; 5. ECOG PS score: 0\~2; 6. Have adequate organ and bone marrow function, defined as follows: neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥80 g/L (neutrophil count in patients with bone marrow involvement) The granulocyte count can be relaxed to ≥1.0×109/L, the platelet count can be relaxed to ≥50×109/L, and the hemoglobin can be relaxed to ≥75 g/L); 7. Liver and renal function: Serum creatinine (Cr) ≤1.5 times the upper limit of normal values; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal values (≤5 times the upper limit of normal values for patients with liver invasion); total bilirubin (TBIL) ) ≤ 1.5 times the upper limit of normal value (for patients with liver invasion ≤ 3 times the upper limit of normal value); 8. Expected survival time more than 3 months; 9. Age 18\~75 years old.
• Exclusion Criteria:
• * 1. The subject's previous anti-tumor treatment history meets one of the following conditions:
• • 1. Those who have received mitoxantrone or Mitoxantrone Hydrochloride Liposome in the past;
• • 2. Previously received treatment with doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin \>360 mg/m2 (converted from other anthracyclines, 1 mg of doxorubicin is equivalent to 2 mg of epirubicin );
• • 3. Patients who have received ASCT within 100 days of first medication, or have received allogeneic hematopoietic stem cell transplantation (Allo-SCT);
• • 4. Within 4 weeks before using this study drug for the first time, you have received anti-tumor treatment (including chemotherapy, targeted therapy, hormone therapy, taking traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs.
• 2. Have a hypersensitivity reaction to any study drug or its ingredients; 3. Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.); 4. Heart function and disease meet one of the following conditions:
• • 1. Long QTc syndrome or QTc interval \>480 ms;
• • 2. Complete left bundle branch block, II or III degree atrioventricular block;
• • 3. Severe, uncontrolled arrhythmia requiring drug treatment;
• • 4. New York Heart Association classification ≥ III;
• • 5. The cardiac left ventricular ejection fraction (LVEF) is less than 50%;
• • 6. Have a history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically severe pericardial disease, or acute ischemic or active disease within 6 months before recruitment Electrocardiographic evidence of sexual conduction system abnormalities.
• • 5. Active infection of hepatitis B and hepatitis C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1×103 copies/mL; hepatitis C virus RNA exceeds 1×103 copies/mL); 6. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 7. Have suffered from other malignant tumors in the past or at the same time (except for non-melanoma basal cell carcinoma of the skin, breast/cervical carcinoma in situ and other malignant tumors that have been effectively controlled without treatment in the past 5 years); 8. Suffer from primary or secondary central nervous system (CNS) lymphoma or have a history of CNS lymphoma at the time of recruitment; 9. Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 10. People with mental disorders/people unable to obtain informed consent; 11.Those who are judged by the researcher to be unsuitable to participate in this trial