Clinical trial · Observational
A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma
NCT06436677CI-TRIAL-00077633AMITYrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T Cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Cutaneous T-Cell Lymphoma/Mycosis Fungoides | Mycosis Fungoides | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| molecular subtype based treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Prospective study group
- description
- 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.
- interventionNames
- Other: molecular subtype based treatment
- label
- Retrospective control group
- description
- The control group included patients with complete baseline information and previous follow-up data in the TACTICAL database, established by Peking University First Hospital in 2009 for cutaneous lymphoma cases.
Primary outcomes (1)
- measure
- time to next treatment (TTNT)
- timeFrame
- From enrollment to the end of treatment at 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTOlsen 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: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC. Blood. 2022 Aug 4;140(5):419-437. doi: 10.1182/blood.2021012057. PMID 34758074
- RESULTChen 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