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

Last updated: May 24, 2024
Sponsor: Peking University First Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoproliferative Disorders

Mycosis Fungoides

Non-hodgkin's Lymphoma

Treatment

molecular subtype based treatment

Clinical Study ID

NCT06436677
PKU2024162-002
SF2024-1-4074
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent;

  • Patients with CTCL who do not respond well to targeted skin therapy (topicalcorticosteroids, 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 controlgroup was greater than 3 months);

Exclusion

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 orimpair the patient's ability to receive protocol therapy, including butnot 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 significantarrhythmias;

  • 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 diseasesor 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 trialdrugs, 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 forparticipation in this study.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: molecular subtype based treatment
Phase:
Study Start date:
May 09, 2024
Estimated Completion Date:
December 31, 2030

Study Description

The study focuses on the impact of treatment strategy selection based on molecular typing for patients with cutaneous T-cell lymphoma. The study aims to evaluate the effect on clinical benefit time and long-term prognosis, assess the safety of the treatment strategy, and explore the interaction between baseline factors and treatment regimens. This research could potentially provide valuable evidence for precision treatment in the context of cutaneous T-cell lymphoma.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

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