Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06433362

CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma

Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-05-29

115

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must fully understand the study and voluntarily sign informed consent.
  • Age between 18 and 70 years (for ages 65-70, physical fitness and tolerance must be evaluated).
  • Expected survival of at least 3 months.
  • Histologically confirmed diagnosis of Peripheral T-cell lymphoma, including ptcl-NOS, AITL, ALCL ALK+ or ALK-, or other PTCL subtypes deemed appropriate.
  • No previous treatment for PTCL, including chemotherapy, targeted therapy, immunotherapy, or local radiotherapy except for symptom relief.
  • At least one measurable lesion according to lugano2014 criteria (lymph node lesions >1.5cm, non-lymph node lesions >1.0cm).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Baseline laboratory values: ANC ≥1.5x10^9/L, Platelet count ≥75x10^9/L, Hemoglobin ≥90 g/L (lower thresholds allowed if bone marrow is involved).
  • Serum creatinine ≤1.5 times upper limit of normal (ULN); ALT and AST ≤2.5 times ULN (≤5 times ULN if liver invasion); bilirubin ≤1.5 times ULN (≤3 times ULN if liver invasion).
Not Eligible

You will not qualify if you...

  • History of prior antitumor therapy.
  • Hypersensitivity to any study drug or its components.
  • Uncontrolled systemic diseases such as active infection, uncontrolled hypertension, or diabetes.
  • Heart conditions including long QTc syndrome (QTc >480 ms), certain heart blocks, serious arrhythmias, New York Heart Association grade ≥II, left ventricular ejection fraction <50%, recent myocardial infarction, unstable angina, or serious pericardial disease.
  • Active hepatitis B or C infection.
  • HIV infection.
  • Other malignant tumors except for controlled non-melanoma skin cancer, breast/cervical carcinoma in situ, or other tumors within the past 5 years.
  • Primary or secondary central nervous system lymphoma or history of CNS lymphoma.
  • Pregnant or breastfeeding women, or patients unwilling to use contraception if of childbearing age.
  • Any other conditions making the subject unsuitable for the study as determined by the investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tianjin Cancer Hospital

Tianjin, China, 300060

Actively Recruiting

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Research Team

J

Jingwei Yu

CONTACT

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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CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma | DecenTrialz