CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma

NCT ID: NCT05458180

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-07
• Study Completion Date: 2025-04-15

Brief Summary

This is a prospective, single arm, multicenter, dose-escalation clinical study to evaluate the safety and efficacy of CMOEP in patients with untreated Peripheral T-cell Lymphoma.

Detailed Description

This is a single arm, multicenter, dose-escalation study which mainly explores the dose limiting toxicity (DLT) of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine, Etoposide and Prednisone（CMOEP） in patients with untreated Peripheral T-cell Lymphoma. Liposomal mitoxantrone hydrochloride will be given on day 1 at three different doses (15 mg/m2, 18 mg/m2, 20 mg/m2) and be combined with Cyclophosphamide, Vincristine, Etoposide and Prednisone. The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned.

Conditions

Peripheral T-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CMOEP

dose-escalation： Untreated Peripheral T-cell Lymphoma Patients will receive sequentially higher doses of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine, Etoposide and Prednisone for 6 cycles (planned) (21 days per cycle). The initial dose of liposomal mitoxantrone hydrochloride is 15 mg/m2.

Group Type: EXPERIMENTAL

Lposomal mitoxantrone hydrochloride,Cyclophosphamide,Vincristine,Etoposide and Prednisone(CMOEP)

Intervention Type: DRUG

Drug: Liposomal mitoxantrone hydrochloride (15 mg/m2, 18 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Drug: Cyclophosphamide (750 mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Drug: Vincristine (1.4mg/ m2，Max dose 2mg) will be administered by an intravenous injection on day 1of each 21-day cycle.

Drug: Etoposide (60 mg/ m2) will be administered by an intravenous infusion on day 1-3 of each 21-day cycle.

Drug: Prednisone (100 mg) will be taken orally from day 1-5 of each 21-day cycle.

Interventions

Lposomal mitoxantrone hydrochloride,Cyclophosphamide,Vincristine,Etoposide and Prednisone(CMOEP)

Drug: Liposomal mitoxantrone hydrochloride (15 mg/m2, 18 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Drug: Cyclophosphamide (750 mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Drug: Vincristine (1.4mg/ m2，Max dose 2mg) will be administered by an intravenous injection on day 1of each 21-day cycle.

Drug: Etoposide (60 mg/ m2) will be administered by an intravenous infusion on day 1-3 of each 21-day cycle.

Drug: Prednisone (100 mg) will be taken orally from day 1-5 of each 21-day cycle.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. Age ≥18, ≤65years, 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.

9. Total Serum creatinine (Scr) ≤1.5X upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN, bilirubin (TBIL)≤1.5X ULN.

Exclusion Criteria

1. The subject had previously received any of the following anti-tumor treatments:1）Subjects who have been treated with mitoxantrone or mitoxantrone liposomes;2）Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin was more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin).

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Insititute & Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Central Contacts

Huilai Zhang, MD；PhD

Role: CONTACT

zhlwgq@126.com

086-02223340123

Jingwei Yu, MD；PhD

Role: CONTACT

jingweiyu@pku.org.cn

086-02223340123

Facility Contacts

Zhang Huilai, PHD

Role: primary

zhlwgq@126.com

086-02223340123

References

Yu J, Sun X, Gao G, Yu L, Wang J, Qiu L, Qian Z, Li W, Zhang H. CMOEP regimen in the treatment of untreated peripheral T-cell lymphoma: a multicenter, single-arm, phase I study. Front Immunol. 2025 Apr 11;16:1551723. doi: 10.3389/fimmu.2025.1551723. eCollection 2025.

Reference Type: DERIVED

PMID: 40292284 (View on PubMed)

Other Identifiers

CSPC-DED-PTCL-K02

Identifier Type: -

Identifier Source: org_study_id