Actively Recruiting
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
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-05-29
115
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a drug combination called CMOEP in patients newly diagnosed with untreated peripheral T-cell lymphoma. This single-arm, open-label, multi-center Phase 2 study focuses on patients aged 18 to 70 years and aims to better understand responses to this treatment in this specific lymphoma type. The treatment involves mitoxantrone hydrochloride liposome given intravenously at a dose of 18 mg/m2 on day 1 of each 21-day cycle. It is combined with cyclophosphamide, vincristine (or similar drugs like vindesine), etoposide given on days 1 to 3, and prednisone. Participants may receive up to six cycles of this therapy. Participants will be closely monitored throughout the treatment cycles and for up to two years to evaluate response rates, survival outcomes, and safety. Assessments include measuring tumor lesions, monitoring cardiac health, and tracking any side effects from the medication. The study follows patients from the start of treatment through post-therapy follow-up to gather comprehensive data on treatment impact and tolerability.
CONDITIONS
Brief Title
CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must fully understand and voluntarily agree to participate by signing informed consent.
- Age between 18 and 70 years (patients 65-70 years require additional fitness evaluation).
- Expected survival of at least 3 months.
- Histologically confirmed peripheral T-cell lymphoma, including PTCL-NOS, AITL, ALCL ALK+ or ALK-, or other investigator-approved subtypes.
- No previous treatments for PTCL, except local radiotherapy to relieve tumor symptoms.
- At least one measurable lesion per Lugano 2014 criteria (lymph node >1.5 cm, non-lymph node >1.0 cm).
- ECOG performance status score of 0 or 1.
- Baseline lab values: ANC ≥1.5×10^9/L, platelet count ≥75×10^9/L, hemoglobin ≥90 g/L (can be lower with bone marrow involvement).
- Kidney and liver function within specified limits (creatinine ≤1.5× ULN, ALT/AST ≤2.5× ULN or ≤5× ULN if liver involved, bilirubin ≤1.5× ULN or ≤3× ULN if liver involved).
You will not qualify if you...
- Prior antitumor therapy for peripheral T-cell lymphoma.
- Allergy or hypersensitivity to any study drug or components.
- Uncontrolled systemic diseases such as active infections, uncontrolled hypertension, or diabetes.
- Significant heart conditions including long QTc, serious arrhythmias, heart failure (NYHA grade ≥II), low ejection fraction (<50%), recent myocardial infarction, or active ECG abnormalities.
- Active hepatitis B or C infection with high viral loads.
- HIV infection.
- Other malignant tumors except certain controlled skin or in situ cancers within past 5 years.
- Central nervous system lymphoma or history of CNS lymphoma.
- Pregnant or breastfeeding women or those unwilling to use contraception.
- Any other condition deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 cycles of 21 days each
Participants receive mitoxantrone hydrochloride liposome combined with cyclophosphamide, vincristine, etoposide, and prednisone in cycles to treat peripheral T-cell lymphoma.
1 visit every 3 weeks for up to 6 cycles (in-person)
Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital
Tianjin, China, 300060
Actively Recruiting
Research Team
J
Jingwei Yu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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