Chi-GVM treatment for relapsed or refractory peripheral T-cell lymphoma

Chidamide Combined With Gemcitabine, Vinorelbine, and Mitoxantrone Hydrochloride Liposome (Chi-GVM) Regimen for the Treatment of Relapsed/Refractory (R/R) Peripheral T-cell Lymphoma (PTCL) :A Multicenter, Open-label, Single-arm Study

This study is testing a new treatment called Chi-GVM for people with relapsed or refractory peripheral T-cell lymphoma to see if it can help them live longer and feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy, doxorubicin
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06211881 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the Chi-GVM regimen for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a type of cancer that is less responsive to standard treatments. The study aims to evaluate the efficacy of this novel treatment approach in improving patient outcomes, particularly in terms of overall survival and progression-free survival. Eligible participants must have a confirmed diagnosis of R/R PTCL and have undergone at least one prior systemic treatment. The trial will assess the treatment's effectiveness based on measurable lesions identified through PET/CT scans.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with a confirmed diagnosis of relapsed or refractory PTCL who have received at least one prior treatment.

Not a fit: Patients with PTCL who have not received any prior systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with relapsed or refractory PTCL.

How similar studies have performed: While there have been studies on HDAC inhibitors showing efficacy in PTCL, the Chi-GVM regimen represents a novel approach that has not been extensively tested.

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

Where this trial is running

Nanjing, Jiangsu

• Hematological Department, People's Hospital of Jiangsu Province — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: wei Xu, Doctor — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Jinhua Liang, Doctor

Conditions Relapsed/Refractory Peripheral T-cell Lymphoma