Clinical trial NCT06436677: A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma
Official title: A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Cutaneous T Cell Lymphoma
Keywords: cutaneous T-cell lymphoma
mycosis fungoides
Sezary syndrome
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Peking University Cancer Hospital & Institute
First posted: 2024-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, retrospective controls were selected from patients with complete baseline information and previous follow-up information in the cutaneous lymphoma case registry system (TACTICAL database) established in 2009. The prospective study group was a prospective enrollment of patients who met the inclusion criteria, and the immunohistochemistry algorithm established by the previous research group was used to determine the molecular subtype. The corresponding treatment regimen was selected according to the subtype. Follow-up was conducted according to the study design and updated by the ISCL, USCLC, and EORTC (2022) as they evaluate treatment response in patients. The primary outcome was time to clinical benefit (TTNT) of first-line therapy, defined as the time from treatment.

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.

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\&amp;amp;#39;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 \&amp;amp;lt; 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.

Primary outcomes:
measure: time to next treatment (TTNT)
timeFrame: From enrollment to the end of treatment at 2 years
Secondary outcomes:
measure: objective response rate (ORR)
timeFrame: From enrollment to the end of treatment at 2 years
measure: time to response (TTR)
timeFrame: From enrollment to the end of treatment at 2 years
measure: progression-free survival (PFS)
timeFrame: From enrollment to the end of treatment at 2 years
measure: overall survival (OS)
timeFrame: From enrollment to the end of treatment at 2 years
Other outcomes:
measure: adverse events and adverse effects
timeFrame: From enrollment to the end of treatment at 2 years
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: YANG WANG, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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: 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.
citation: 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.