CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma

Peripheral T Cell Lymphoma Clinical Trial

Official title:

A Single Arm, Open Label, Multi-center Study of Mitoxantrone Hydrochloride Liposome With Cyclophosphamide, Vincristine, Etoposide and Prednisone (CMOEP) in Treatment-Naive Patients With Peripheral T-Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06433362
• Other study ID #: CSPC-DED-PTCL-K07
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Jingwei Yu
• Phone: 86-15022015208
• Email: jingweiyu[@]pku.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOEP in patients with untreated peripheral T-cell lymphoma.

Description:

This is a single-arm, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with Cyclophosphamide, Vincristine, Etoposide and Prednisone(CMOEP) in patients with untreated Peripheral T-cell Lymphoma.Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with cyclophosphamide, vincristine, etoposide and prednisone.Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1.Subjects fully understand and voluntarily participate in this study and sign informed consent.

2. Age =18, =70years(for 65-70 years old, researchers need to comprehensively evaluate the physical fitness and tolerance of patients), no gender limitation.

3. Expected survival = 3 months. 4.Histologically confirmed diagnosis of Peripheral T-cell lymphoma: 1) Peripheral T-cell lymphoma unspecified (ptcl-NOS) 2) Angioimmunoblastic T-cell lymphoma (AITL) 3) Anaplastic large T-cell lymphoma (ALCL), ALK+ 4) Anaplastic large T-cell lymphoma (ALCL), ALK- 5) Other subtypes of PTCL that the investigator think can be included in the group.

5.No previous treatment for PTCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except for local radiotherapy to alleviate tumor related symptoms), surgical treatment.

6.Subjects must have at least one evaluable or measurable lesion per lugano2014 criteria: for lymph node lesions, the length and diameter should be >1.5cm; For non-lymph node lesions, the length and diameter should be >1.0cm.

7.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. 8.The following baseline laboratory criteria are required: Absolute neutrophil count (ANC) =1.5×10^9/L, Platelet count (PLT) =75×10^9/L, Hemoglobin(HB)= 90 g/L(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) =1.0×10^9/L, Platelet count (PLT) =50×10^9/L, Hemoglobin(HB)= 75g/L).

9.Total Serum creatinine (Scr) =1.5X upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5X ULN(For patients with liver invasion =5X ULN), bilirubin (TBIL)=1.5X ULN(For patients with liver invasion =3X ULN ).

Exclusion Criteria:

• 1.Subjects with a history of prior antitumor therapy. 2.Hypersensitivity to any study drug or its components. 3.Uncontrolled systemic diseases (such as active infection, uncontrolled 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, grade II or III atrioventricular block;3)Serious and uncontrolled arrhythmias requiring drug treatment;4)New York Heart Association grade = II;5)Cardiac ejection fraction (LVEF)<50%;6)A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.

5.Hepatitis B and hepatitis C active infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than 1x10^3 copy/mL; hepatitis C virus RNA high than 1x10^3 copy/mL).

6.Human immunodeficiency virus (HIV) infection (HIV antibody positive). 7.Patients with other malignant tumors, except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ and other tumor during the past 5 years.

8.Patients with primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma.

9.Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures.

10.Unsuitable subjects for this study determined by the investigator.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

Intervention

Drug:
• CMOEP
Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (18 mg/m^2) on day 1, every 3 weeks; Drug: Cyclophosphamide Cyclophosphamide(750 mg/m^2) on day 1,every 3 weeks; Drug: Vincristine Vincristine (1.4mg/ m2,Max dose 2mg) will be administered by an intravenous injection on day 1(Or at the discretion of the investigator, use other vinblastine drugs with the same mechanism, such as vindesine 3 mg/m2, the maximum dose of 4mg),every 3 weeks; Drug: Etoposide Etoposide (60 mg/ m2) will be administered by an intravenous infusion on day 1-3,every 3 weeks;

Locations

Country	Name	City	State
China	Tianjin Cancer Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate (CRR)	Response is assessed according to the lugano criteria.	2 year
Secondary	Overall Response Rate (ORR)	Response is assessed according to the lugano criteria.	2 year
Secondary	Progression-Free-Survival (PFS)	From the date of the first dose of therapy is given until disease progression, death or last follow-up.	2 year
Secondary	Overall survival (OS)	From the date of inclusion to date of death, irrespective of cause.	2 year
Secondary	Safety and Tolerability	The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.Hematologic and non-hematologic toxicity.	From the first day of medication to 28 days after the last dose
Secondary	Changes in cardiac safety indicators	such as LVEF% change from baseline, cardiac injury indicators, etc.	2 year