A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma
- Conditions
- Cutaneous T-Cell Lymphoma/Mycosis FungoidesCutaneous T Cell Lymphoma
- Interventions
- Other: molecular subtype based treatment
- Registration Number
- NCT06436677
- Lead Sponsor
- Peking University First Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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);
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Received other anti-tumor therapy other than skin-targeted therapy (phototherapy, topical hormones or nitrogen mustard) within the past 1 month prior to enrollment;
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Patients with 2 or more types of primary cutaneous T-cell lymphoma at the same time;
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Combined with other malignant tumors, still receiving anti-tumor therapy;
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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;
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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;
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Pregnant (or intending to become pregnant within 2 years) or lactating females;
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Concomitant participation in interventional clinical trials of other clinical trial drugs, except for questionnaire surveys or observational studies;
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Any situation in which the programme is not in compliance;
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Other conditions that in the opinion of the investigator are not suitable for participation in this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective study group molecular subtype based treatment The group included patients with confirmed cutaneous T-cell lymphoma (CTCL) based on clinical features and histopathology from three research units: Peking University First Hospital, Peking University Third Hospital, and Beijing Institute of Cancer Prevention and Treatment. According to the immunohistochemistry algorithm established previously, the formalin-fixed and paraffin-embedded skin lesions of the patients will be stained. Patients will be assigned to different molecular subtypes, and the treatment strategy will be selected based on the classification.
- Primary Outcome Measures
Name Time Method time to next treatment (TTNT) From enrollment to the end of treatment at 2 years The time to treatment failure (TTNT) is defined as the duration from the start of treatment to when the treatment is switched to the next systemic therapy or until the patient passes away. Introducing new skin-directed therapy (SDT) alongside topical therapy doesn't indicate treatment failure unless the systemic treatment is changed. If the skin lesion worsens and needs local radiotherapy, it's considered that the systemic therapy has failed. The date of discontinuation of systemic therapy is used when treatment is stopped due to disease progression without further treatment.
- Secondary Outcome Measures
Name Time Method progression-free survival (PFS) From enrollment to the end of treatment at 2 years The progression-free survival (PFS) is defined as the period from the beginning of treatment until the first instance of disease progression or death from any cause. Disease progression is defined as advancement to a higher TNMB stage (excluding changes from T1a or T2a to T1b or T2b) or death due to the disease.
overall survival (OS) From enrollment to the end of treatment at 2 years The overall survival (OS) is defined as the period from the beginning of treatment to the point of death from any cause.
objective response rate (ORR) From enrollment to the end of treatment at 2 years The objective response rate (ORR) is defined as the proportion of patients with complete response (CR) and partial response (PR) as per the Primary cutaneous lymphoma: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC (2022). The first CR or PR is achieved and repeated after 4 weeks for confirmation.
time to response (TTR) From enrollment to the end of treatment at 2 years Time to response (TTR) is defined as the duration from the start of treatment to the first meeting of CR or PR criteria.
Trial Locations
- Locations (3)
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China