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

NCT ID: NCT06436677

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-09
• Study Completion Date: 2030-12-31

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.

Conditions

Cutaneous T-Cell Lymphoma/Mycosis Fungoides; Cutaneous T Cell Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Prospective study group

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.

molecular subtype based treatment

Intervention Type: OTHER

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.

Retrospective control group

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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'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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yang WANG

The Chief of Department of Dermatology and Venereology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

YANG WANG, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Wang, MD

Role: CONTACT

yangwang_dr@bjmu.edu.cn

86-10-83572350

Facility Contacts

YANG ZHANG, MD

Role: primary

yangwang_dr@bjmu.edu.cn

86-10-83572350

ZHUOJING CHEN, MD

Role: backup

chenzhuojing15@gmail.com

86+01083572350

WENQING LI, MD

Role: primary

pan-kf@263.net

CHUNLEI ZHANG, MD

Role: primary

zhangchunleius@163.com

References

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.

Reference Type: RESULT

PMID: 34758074 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37585188 (View on PubMed)

Other Identifiers

SF2024-1-4074

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PKU2024162-002

Identifier Type: -

Identifier Source: org_study_id