RecruitingNCT06436677

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

Sponsor

Peking University First Hospital

Enrollment

100 participants

Start Date

May 9, 2024

Study Type

OBSERVATIONAL

Conditions

Cutaneous T Cell Lymphoma Cutaneous T-Cell Lymphoma/Mycosis Fungoides

Summary

Cutaneous T-cell lymphoma (CTCL) is a group of diseases resulting from clonal hyperplasia of memory T cells in the skin. The increasing incidence and high treatment costs have posed significant challenges to public health and the economy. Current treatment guidelines only provide partial control, leading to varying remission times and recurrence rates. This study aims to use molecular subtyping and immunohistochemistry to guide treatment selection for CTCL patients, aiming to prolong clinical benefit, improve treatment safety, and reduce economic burden.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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 Criteria18

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\&amp;#39;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 \&amp;lt; 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.

Interventions

OTHERmolecular subtype based treatment

The immunohistochemistry algorithm established by the previous research group was used to determine the molecular subtype, and the corresponding treatment plan was selected according to the subtype. Such as for TCyEM patients, interferon-based immunomodulatory therapy was selected, and TCM-type patients were treated with retinoids.