Last updated: January 9, 2024
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Lymphoma
Non-hodgkin's Lymphoma
Treatment
Chi-GVM
Clinical Study ID
NCT06211881
2023-SR-519
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- R/R PTCL confirmed by pathological tissue [including peripheral T-cell lymphoma-nototherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and ALK+anaplastic large cell lymphoma (ALCL) , ALK-ALCL, monotypic epithelial intestinalT-cell lymphoma (MEITL), etc.], the diagnostic criteria refer to the 2022 WHOdiagnostic criteria; 2. Have had at least one previous systemic treatment [includingchemotherapy, autologous hematopoietic stem cell transplantation (ASCT) ), etc.]Patients who have no remission or relapse after remission; 3. Sign written informedconsent and be able to comply with the visits and related procedures specified in theprotocol; 4. Whole-body PET/CT performed 28 days before study enrollment must be Atleast 1 evaluable or measurable lesion that meets the Lugano2014 criteria: lymph nodelesions, measurable lymph nodes must have a long diameter >1.5 cm; non-lymph nodelesions, measurable extranodal lesions must have a long diameter >1.0 cm; 5. ECOG PSscore: 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 (neutrophilcount in patients with bone marrow involvement) The granulocyte count can be relaxedto ≥1.0×109/L, the platelet count can be relaxed to ≥50×109/L, and the hemoglobin canbe relaxed to ≥75 g/L); 7. Liver and renal function: Serum creatinine (Cr) ≤1.5 timesthe upper limit of normal values; aspartate aminotransferase (AST) and alanineaminotransferase (ALT) ≤2.5 times the upper limit of normal values (≤5 times the upperlimit 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 timesthe upper limit of normal value); 8. Expected survival time more than 3 months; 9. Age 1875 years old.
- R/R PTCL confirmed by pathological tissue [including peripheral T-cell lymphoma-nototherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and ALK+anaplastic large cell lymphoma (ALCL) , ALK-ALCL, monotypic epithelial intestinalT-cell lymphoma (MEITL), etc.], the diagnostic criteria refer to the 2022 WHOdiagnostic criteria; 2. Have had at least one previous systemic treatment [includingchemotherapy, autologous hematopoietic stem cell transplantation (ASCT) ), etc.]Patients who have no remission or relapse after remission; 3. Sign written informedconsent and be able to comply with the visits and related procedures specified in theprotocol; 4. Whole-body PET/CT performed 28 days before study enrollment must be Atleast 1 evaluable or measurable lesion that meets the Lugano2014 criteria: lymph nodelesions, measurable lymph nodes must have a long diameter >1.5 cm; non-lymph nodelesions, measurable extranodal lesions must have a long diameter >1.0 cm; 5. ECOG PSscore: 0
Exclusion
Exclusion Criteria:
- The subject's previous anti-tumor treatment history meets one of the followingconditions:
- Those who have received mitoxantrone or Mitoxantrone Hydrochloride Liposome inthe past;
- Previously received treatment with doxorubicin or other anthracyclines, with atotal cumulative dose of doxorubicin >360 mg/m2 (converted from otheranthracyclines, 1 mg of doxorubicin is equivalent to 2 mg of epirubicin );
- Patients who have received ASCT within 100 days of first medication, or havereceived allogeneic hematopoietic stem cell transplantation (Allo-SCT);
- Within 4 weeks before using this study drug for the first time, you have receivedanti-tumor treatment (including chemotherapy, targeted therapy, hormone therapy,taking traditional Chinese medicine with anti-tumor activity, etc.) orparticipated in other clinical trials and received clinical trial drugs.
- Have a hypersensitivity reaction to any study drug or its ingredients; 3.Uncontrollable systemic diseases (such as advanced infection, uncontrollablehypertension, diabetes, etc.); 4. Heart function and disease meet one of the followingconditions:
- 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 unstableventricular arrhythmia or any other arrhythmia requiring treatment, clinicallysevere pericardial disease, or acute ischemic or active disease within 6 monthsbefore recruitment Electrocardiographic evidence of sexual conduction systemabnormalities.
- Active infection of hepatitis B and hepatitis C (hepatitis B virus surface antigenis positive and hepatitis B virus DNA exceeds 1×103 copies/mL; hepatitis C virus RNAexceeds 1×103 copies/mL); 6. Human immunodeficiency virus (HIV) infection (HIVantibody positive); 7. Have suffered from other malignant tumors in the past or at thesame time (except for non-melanoma basal cell carcinoma of the skin, breast/cervicalcarcinoma in situ and other malignant tumors that have been effectively controlledwithout treatment in the past 5 years); 8. Suffer from primary or secondary centralnervous system (CNS) lymphoma or have a history of CNS lymphoma at the time ofrecruitment; 9. Pregnant, lactating women and patients of childbearing age who areunwilling to take contraceptive measures; 10. People with mental disorders/peopleunable to obtain informed consent; 11.Those who are judged by the researcher to beunsuitable to participate in this trial
Study Design
Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Chi-GVM
Phase:
Study Start date:
October 25, 2023
Estimated Completion Date:
September 30, 2025
Study Description
Connect with a study center
Hematological Department, People's Hospital of Jiangsu Province
Nanjing, Jiangsu 210029
ChinaActive - Recruiting
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