CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma

May 26, 2024 updated by: Tianjin Medical University Cancer Institute and Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

115

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China, 300060
        • Recruiting
        • Tianjin Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CMOEP
Mitoxantrone Hydrochloride Liposome with Cyclophosphamide, Vincristine, Etoposide and Prednisone
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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate (CRR)
Time Frame: 2 year
Response is assessed according to the lugano criteria.
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: 2 year
Response is assessed according to the lugano criteria.
2 year
Progression-Free-Survival (PFS)
Time Frame: 2 year
From the date of the first dose of therapy is given until disease progression, death or last follow-up.
2 year
Overall survival (OS)
Time Frame: 2 year
From the date of inclusion to date of death, irrespective of cause.
2 year
Safety and Tolerability
Time Frame: From the first day of medication to 28 days after the last dose
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
Changes in cardiac safety indicators
Time Frame: 2 year
such as LVEF% change from baseline, cardiac injury indicators, etc.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Study Director: Huilai Zhang, Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital
  • Study Director: Qingyuan Zhang, The Second Affiliated Hospital of Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 26, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 26, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-DED-PTCL-K07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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