A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma

Launched by PEKING UNIVERSITY FIRST HOSPITAL · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat cutaneous T-cell lymphoma (CTCL), a type of cancer that affects the skin. The researchers want to find out if using specific tests to understand the cancer at a molecular level can help doctors choose the best treatment for patients. The goal is to improve how long patients benefit from their treatments, make those treatments safer, and lower costs associated with care.

To participate in this study, patients need to be between 18 and 75 years old and have CTCL that hasn't responded well to standard skin therapies. They should also expect to live for at least three more months. The study is currently looking for participants, and anyone interested will need to sign a consent form. Throughout the trial, participants will receive treatments based on their unique cancer profiles, but some health conditions or recent treatments may prevent them from joining. This trial could be an important step in finding more effective therapies for people suffering from CTCL.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent;
• • Patients with CTCL who do not respond well to targeted skin therapy (topical corticosteroids, nitrogen mustard, or phototherapy) in the early stage (stage I-IIA) and advanced stage (stage IIB-IV);
• • Age 18-75 years;
• • Expected survival time greater than 3 months (follow-up for the historical control group was greater than 3 months);
• Exclusion Criteria:
• • Received other anti-tumor therapy other than skin-targeted therapy (phototherapy, topical hormones or nitrogen mustard) within the past 1 month prior to enrollment;
• • Patients with 2 or more types of primary cutaneous T-cell lymphoma at the same time;
• • Combined with other malignant tumors, still receiving anti-tumor therapy;
• * Has any other active disease that may increase the risk of protocol therapy or impair the patient\'s ability to receive protocol therapy, including but not limited to:
• • Comorbid epilepsy;
• • Comorbid autoimmune diseases;
• • Combined with hepatic decompensation;
• • Patients with renal insufficiency and creatinine clearance \< 50ml/min;
• * Have an uncontrollable medical condition, including but not limited to:
• • Ongoing or active infection;
• • Clinically significant healing or non-healing wounds;
• • Symptomatic congestive heart failure, unstable angina, clinically significant arrhythmias;
• • Significant lung disease (e.g., shortness of breath at rest or light activity, or need for supplemental oxygen for any reason);
• • Diseases/conditions that affect study compliance, such as infectious diseases or psychiatric illnesses/social situations, that are uncontrollable;
• • Pregnant (or intending to become pregnant within 2 years) or lactating females;
• • Concomitant participation in interventional clinical trials of other clinical trial drugs, except for questionnaire surveys or observational studies;
• • Any situation in which the programme is not in compliance;
• • Other conditions that in the opinion of the investigator are not suitable for participation in this study.