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

Cutaneous T Cell Lymphoma Clinical Trial

— AMITY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06436677
• Other study ID #: PKU2024162-002
• Secondary ID: SF2024-1-4074
• Status: Recruiting
• Start date: May 9, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: May 2024
• Source: Peking University First Hospital
• Contact: Yang Wang, MD
• Phone: 86-10-83572350
• Email: yangwang_dr[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous T Cell Lymphoma
• Cutaneous T-Cell Lymphoma/Mycosis Fungoides
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral
• Mycoses
• Mycosis Fungoides

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University First Hospital	Peking University Cancer Hospital & Institute, Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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 — View 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, Quaglin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events and adverse effects	Adverse events and adverse effects: The Preferred Term (PT) for adverse events and the Systemic Organ Classification (SOC) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). For the statistics of adverse event rates, each patient will be counted at most once per SOC and per PT. For the same adverse event that occurs multiple times in the same patient, the severity will be counted according to the severity of multiple occurrences. All adverse events (pre- and intra-treatment adverse events) are included in the list of adverse events	From enrollment to the end of treatment at 2 years
Primary	time to next treatment (TTNT)	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.	From enrollment to the end of treatment at 2 years
Secondary	objective response rate (ORR)	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.	From enrollment to the end of treatment at 2 years
Secondary	time to response (TTR)	Time to response (TTR) is defined as the duration from the start of treatment to the first meeting of CR or PR criteria.	From enrollment to the end of treatment at 2 years
Secondary	progression-free survival (PFS)	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.	From enrollment to the end of treatment at 2 years
Secondary	overall survival (OS)	The overall survival (OS) is defined as the period from the beginning of treatment to the point of death from any cause.	From enrollment to the end of treatment at 2 years