## Protocol Section
### Identification Module
**NCT ID:** NCT06436677

**Acronym:** AMITY

**Brief Title:** 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

#### Organization Study ID Info
**ID:** PKU2024162-002
#### Organization
**Class:** OTHER
**Full Name:** Peking University First Hospital
#### Secondary ID Infos
**Domain:** Capital's Funds for Health Improvement and Research
**ID:** SF2024-1-4074
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2030-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-09

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Peking University Third Hospital

**Class:** OTHER

**Name:** Peking University Cancer Hospital & Institute

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking University First Hospital

#### Responsible Party

**Investigator Affiliation:** Peking University First Hospital

**Investigator Full Name:** Yang WANG

**Investigator Title:** The Chief of Department of Dermatology and Venereology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Cutaneous T-Cell Lymphoma/Mycosis Fungoides

- Cutaneous T Cell Lymphoma

**Keywords:**

- cutaneous T-cell lymphoma

- mycosis fungoides

- Sezary syndrome

### Design Module

#### Bio Spec

**Description:** Formalin fixed and paraffin embedded skin biopsy tissue

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 2 Years

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Other: molecular subtype based treatment

**Label:** Prospective study group

#### Arm Group 2

**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.

**Label:** Retrospective control group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Prospective study group

**Description:** 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.

**Name:** molecular subtype based treatment

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** 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

**Measure:** adverse events and adverse effects

**Time Frame:** From enrollment to the end of treatment at 2 years

#### Primary Outcomes

**Description:** 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.

**Measure:** time to next treatment (TTNT)

**Time Frame:** From enrollment to the end of treatment at 2 years

#### Secondary Outcomes

**Description:** 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.

**Measure:** objective response rate (ORR)

**Time Frame:** From enrollment to the end of treatment at 2 years

**Description:** Time to response (TTR) is defined as the duration from the start of treatment to the first meeting of CR or PR criteria.

**Measure:** time to response (TTR)

**Time Frame:** From enrollment to the end of treatment at 2 years

**Description:** 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.

**Measure:** progression-free survival (PFS)

**Time Frame:** From enrollment to the end of treatment at 2 years

**Description:** The overall survival (OS) is defined as the period from the beginning of treatment to the point of death from any cause.

**Measure:** overall survival (OS)

**Time Frame:** From enrollment to the end of treatment at 2 years

### Eligibility Module

**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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yangwang_dr@bjmu.edu.cn

**Name:** Yang Wang, MD

**Phone:** 86-10-83572350

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** yangwang_dr@bjmu.edu.cn

- **Name:** YANG ZHANG, MD

- **Phone:** 86-10-83572350

- **Role:** CONTACT

***Contact 2:***

- **Email:** chenzhuojing15@gmail.com

- **Name:** ZHUOJING CHEN, MD

- **Phone:** 86+01083572350

- **Role:** CONTACT

***Contact 3:***

- **Name:** YANG WANG, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** ZHUOJING CHEN, MD

- **Role:** SUB_INVESTIGATOR

**Country:** China

**Facility:** Peking University First Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100034

**Location 2:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** pan-kf@263.net

- **Name:** WENQING LI, MD

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Cancer Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100142

**Location 3:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** zhangchunleius@163.com

- **Name:** CHUNLEI ZHANG, MD

- **Role:** CONTACT

**Country:** China

**Facility:** Peking University Third Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100191

#### Overall Officials

**Official 1:**

**Affiliation:** Peking University First Hospital

**Name:** YANG WANG, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** IPD will only be shared within the participating medical units in the study, including study protocol, informed consent form, clinical study report and statistical analysis plan. Any other institutes requesting for IPD needs to be reviewed by the National Clinical Center for Skin and Immune Diseases in China.

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 34758074

**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.

**PMID:** 37585188

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000008228

- Term: Lymphoma, Non-Hodgkin

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: HIGH

- As Found: Mycosis

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M18829

- Name: Lymphoma, T-Cell

- Relevance: HIGH

- As Found: T-cell Lymphoma

- ID: M18833

- Name: Lymphoma, T-Cell, Peripheral

- Relevance: HIGH

- As Found: T-cell Lymphoma

- ID: M12137

- Name: Mycosis Fungoides

- Relevance: HIGH

- As Found: Mycosis Fungoides

- ID: M18832

- Name: Lymphoma, T-Cell, Cutaneous

- Relevance: HIGH

- As Found: Cutaneous T-Cell Lymphoma

- ID: M15560

- Name: Sezary Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11222

- Name: Lymphoma, Non-Hodgkin

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T4496

- Name: Peripheral T-cell Lymphoma

- Relevance: HIGH

- As Found: T-cell Lymphoma

- ID: T3986

- Name: Mycosis Fungoides

- Relevance: HIGH

- As Found: Mycosis Fungoides

- ID: T1689

- Name: Cutaneous T-cell Lymphoma

- Relevance: HIGH

- As Found: Cutaneous T-Cell Lymphoma

- ID: T5200

- Name: Sezary Syndrome

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009181

- Term: Mycoses

- ID: D000008223

- Term: Lymphoma

- ID: D000016399

- Term: Lymphoma, T-Cell

- ID: D000016411

- Term: Lymphoma, T-Cell, Peripheral

- ID: D000009182

- Term: Mycosis Fungoides

- ID: D000016410

- Term: Lymphoma, T-Cell, Cutaneous

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10407

- Name: Interferons

- Relevance: LOW

- As Found: Unknown

- ID: M8681

- Name: Formaldehyde

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
