Status:
RECRUITING
Chi-GVM Regimen for the Treatment of R/R PTCL
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Relapsed/Refractory Peripheral T-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Peripheral T-cell lymphoma (PTCL) is a heterogeneous group of lymphoproliferative diseases caused by mature T cells, accounting for approximately 10% of non-Hodgkin lymphomas (NHL). PTCLs have a worse...
Detailed Description
Peripheral T-cell lymphoma (PTCL) is a heterogeneous group of lymphoproliferative diseases caused by mature T cells, accounting for approximately 10% of non-Hodgkin lymphomas (NHL). Peripheral T-cell ...
Eligibility Criteria
Inclusion
- 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
- 1\. The subject's previous anti-tumor treatment history meets one of the following conditions:
- Those who have received mitoxantrone or Mitoxantrone Hydrochloride Liposome in the past;
- 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 );
- Patients who have received ASCT within 100 days of first medication, or have received allogeneic hematopoietic stem cell transplantation (Allo-SCT);
- 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:
- Long QTc syndrome or QTc interval \>480 ms;
- Complete left bundle branch block, II or III degree atrioventricular block;
- Severe, uncontrolled arrhythmia requiring drug treatment;
- New York Heart Association classification ≥ III;
- The cardiac left ventricular ejection fraction (LVEF) is less than 50%;
- 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
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06211881
Start Date
October 25 2023
End Date
September 30 2025
Last Update
January 18 2024
Active Locations (1)
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1
Hematological Department, People's Hospital of Jiangsu Province
Nanjing, Jiangsu, China, 210029