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

NCT06436677 | Recruiting DMC

• 2 other identifiers: PKU2024162-002SF2024-1-4074
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

cutaneous T-cell lymphoma; mycosis fungoides; Sezary syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• objective response rate (ORR)

  From enrollment to the end of treatment at 2 years

• time to response (TTR)

  From enrollment to the end of treatment at 2 years

• progression-free survival (PFS)

  From enrollment to the end of treatment at 2 years

• overall survival (OS)

  From enrollment to the end of treatment at 2 years

Other Outcomes (1)

• adverse events and adverse effects

  From enrollment to the end of treatment at 2 years

Study Arms (2)

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.

Other: molecular subtype based treatment

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.

Interventions

molecular subtype based treatment 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.

Prospective study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Third Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (3)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 34758074 RESULT

• 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 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Formalin fixed and paraffin embedded skin biopsy tissue

MeSH Terms

Conditions

Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous; Sezary Syndrome

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• YANG WANG, MD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Wang, MD

CONTACT

86-10-83572350; yangwang_dr@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Chief of Department of Dermatology and Venereology

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: May 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)