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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое molecular 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.

Первичные конечные точки

• time to next treatment (TTNT) [Срок оценки: From enrollment to the end of treatment at 2 years]

Вторичные конечные точки (4)

• objective response rate (ORR) [Срок оценки: From enrollment to the end of treatment at 2 years]
• time to response (TTR) [Срок оценки: From enrollment to the end of treatment at 2 years]
• progression-free survival (PFS) [Срок оценки: From enrollment to the end of treatment at 2 years]
• overall survival (OS) [Срок оценки: From enrollment to the end of treatment at 2 years]

Критерии участия

Критерии включения

• 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);

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 3 центра

• Peking University First Hospital — Пекин
• Beijing Cancer Hospital — Пекин
• Peking University Third Hospital — Пекин

Публикации

• Olsen EA, Whittaker S, Willemze R, Pinter-Brown L, Foss F, Geskin L, Schwartz L, Horwitz S, Guitart J, Zic J, Kim YH, Wood GS, Duvic M, Ai W, Girardi M, Gru A, Guenova E, Hodak E, Hoppe R, Kempf W, Kim E, Lechowicz MJ, Ortiz-Romero P, Papadavid E, Quaglino P, Pittelkow M, Prince HM, Sanches JA, Sugaya M, Vermeer M, Zain J, Knobler R, Stadler R, Bagot M, Scarisbrick J. Primary cutaneous lymphoma: r PMID 34758074
• Chen Z, Lin Y, Qin Y, Qu H, Zhang Q, Li Y, Wen Y, Sun J, Tu P, Gao P, Wang Y. Prognostic Factors and Survival Outcomes Among Patients With Mycosis Fungoides in China: A 12-Year Review. JAMA Dermatol. 2023 Oct 1;159(10):1059-1067. doi: 10.1001/jamadermatol.2023.2634. PMID 37585188

Идентификаторы

NCT: NCT06436677 · PKU2024162-002 · SF2024-1-4074

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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