CMOP Regimen and Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

NCT05896813 | Unknown

• 1 other identifier: CSPC-DED-PTCL-K
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral T-cell lymphoma (PTCL) is a highly heterogeneous and aggressive non-Hodgkin's lymphoma. The incidence rate of PTCL in China is much higher than the global average, and there is no unified standard treatment for initial PTCL. Currently, the CHOP regimen is widely used as first-line treatment. However, the overall response rate is still low, and effective therapies need to be explored. Epigenetics and genetics jointly determine critical features of tumors, and exploring new treatment strategies and developing targeted drugs based on deep understanding of the pathogenesis is of significant importance. The combined application of DNMT inhibitors and HDAC inhibitors has strong scientific support. The Phase II clinical study of Mitoxantrone Hydrochloride Liposome in treating relapsed or refractory PTCL achieved positive results and regulatory approval. The CMOP regimen combining Mitoxantrone Hydrochloride Liposome with Chidamide is worth exploring for initial PTCL treatment.

Conditions

Newly Diagnosed Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• ORR

  overall response rate

  1 year

Secondary Outcomes (4)

• CRR

  1 year

• 2-year PFS

  2 years

• 2-year OS

  2 years

• SAE

  2 years

Study Arms (1)

CMOP+Chi

EXPERIMENTAL

Cyclophosphamide: 750 mg/m2, d1; Mitoxantrone Hydrochloride Liposome: 20 mg/m2, d1; Vincristine: 1.4 g/m2, d1 (maximum dose of 2 mg), or vindesine 3 mg/m2, d1; Prednisone: 60 mg/m2, d1-d5; Chidamide:20 mg, biw. The treatment is administered every 3 weeks as a cycle and lasts for a total of 6 cycles.

Drug: CMOP+Chidamide

Interventions

CMOP+Chidamide DRUG

Cyclophosphamide: 750 mg/m2, d1; Mitoxantrone Hydrochloride Liposome: 20 mg/m2, d1; Vincristine: 1.4 g/m2, d1 (maximum dose of 2 mg), or vindesine 3 mg/m2, d1; Prednisone: 60 mg/m2, d1-d5; Chidamide:20 mg, biw. The treatment is administered every 3 weeks as a cycle and lasts for a total of 6 cycles.

CMOP+Chi

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient understands the content of this study, voluntarily participates in the study, and signs the informed consent form (ICF);
• Age: 18-80 years;
• Expected survival time ≥ 3 months;
• Histologically confirmed PTCL, one of the following subtypes:
• PTCL not otherwise specified (PTCL-NOS)
• Nodal T follicular helper (Tfh) cell lymphoma
• At least one measurable or evaluable lesion that meets the Lugano2014 criteria: for lymph node lesions, the longest diameter should be \>1.5 cm, and for extranodal lesions, the longest diameter should be \>1.0 cm;
• ECOG score 0-2 points;
• Bone marrow function: neutrophil count ≥ 1.5×109/L, platelet count ≥ 75×109/L, hemoglobin ≥ 80 g/L (for patients with bone marrow involvement, the neutrophil count can be relaxed to ≥ 1.0×109/L, platelet count can be relaxed to ≥ 50×109/L, hemoglobin can be relaxed to ≥ 75 g/L);
• Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal, AST and ALT ≤ 2.5 times the upper limit of normal (≤ 5 times the upper limit of normal for patients with liver involvement), and total bilirubin ≤ 1.5 times the upper limit of normal (≤ 3 times the upper limit of normal for patients with liver involvement).

You may not qualify if:

• \. Hypersensitivity to any study drug or its components; 2. Uncontrollable systemic diseases (such as advanced infection, uncontrolled hypertension, diabetes, etc.); 3. One of the following applies to cardiac function and disease:
• Long QT syndrome or QTc interval \>480 ms;
• Complete left bundle branch block, II or III degree atrioventricular block;
• Severe, uncontrolled arrhythmia requiring medication;
• New York Heart Association (NYHA) grade ≥ III;
• Left ventricular ejection fraction (LVEF) \<50%;
• A history of acute myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or other arrhythmias or clinically significant pericardial disease requiring treatment within the six months prior to recruitment or evidence of acute ischemic or active conduction system abnormalities on the electrocardiogram; 4. Active hepatitis B or C infection (hepatitis B surface antigen positive and hepatitis B virus DNA \> 1x104 copies/mL; hepatitis C virus RNA \> 1x104 copies/mL); 5. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 6. Previously or currently diagnosed with other malignant tumors (except for non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated and effectively controlled within the past five years); 7. Central nervous system (CNS) lymphoma or a history of CNS lymphoma; 8. Pregnant or lactating women and childbearing patients who do not want to take contraceptive measures; 9. Other situations judged by the researcher to be unsuitable for participation in this study.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Hematological Department, People's Hospital of Jiangsu Province

Nanjing, Jiangsu, 210029, China

RECRUITING

Central Study Contacts

Jinhua Liang

CONTACT

15952032421; 1151525490@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 9, 2023
• Study Start: March 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 9, 2023

Record last verified: 2023-05

Locations

CN (1)