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NCT Number: NCT06436677

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

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.

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Key information

Conditions

Cutaneous T-Cell Lymphoma/Mycosis Fungoides Cutaneous T Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Mycosis Fungoides Neoplasms Neoplasms by Histologic Type Sezary Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. time to next treatment (TTNT)

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

    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.

Secondary outcomes

  1. objective response rate (ORR)

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

    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.

  2. time to response (TTR)

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

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

  3. progression-free survival (PFS)

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

    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.

  4. overall survival (OS)

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

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

Other outcomes

  1. adverse events and adverse effects

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Wang, MD

CONTACT

[email protected]

86-10-83572350

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Peking University Cancer Hospital & Institute
  • Peking University Third Hospital

Registry information

Acronym: AMITY

Important dates

Study start
2024
Primary completion
2026
Study completion
2030
First posted
May 31, 2024
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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