Molecular subtyping for treating cutaneous T-cell lymphoma

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

This study is testing if personalized treatment plans based on specific molecular types can help people with cutaneous T-cell lymphoma feel better and live longer.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT06436677 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of treatment strategies based on molecular subtyping for patients with cutaneous T-cell lymphoma (CTCL). It aims to assess the impact of these tailored treatments on clinical benefit time and long-term prognosis while ensuring treatment safety. By utilizing immunohistochemistry and molecular typing, the research seeks to provide evidence for precision medicine in managing CTCL, addressing the challenges of varying remission times and recurrence rates. The study will also explore how baseline factors interact with treatment regimens to optimize patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with CTCL who have not responded well to standard skin therapies.

Not a fit: Patients with multiple types of primary cutaneous T-cell lymphoma or those currently undergoing other anti-tumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and safer treatment options for patients with cutaneous T-cell lymphoma.

How similar studies have performed: While there is ongoing research in precision medicine for CTCL, this specific approach using molecular subtyping is relatively novel.

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.

Where this trial is running

Beijing, Beijing Municipality and 2 other locations

• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Yang Wang, Md — Peking University First Hospital
• Study coordinator: Yang Wang, MD

Conditions Cutaneous T-Cell Lymphoma/Mycosis Fungoides; Cutaneous T Cell Lymphoma; cutaneous T-cell lymphoma; mycosis fungoides; Sezary syndrome