A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Comorbid epilepsy;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
molecular subtype based treatment
Other interventionThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Prospective study group1 intervention
Group B: Retrospective control group0 interventions
Trial outcomes
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.
Time frame
From enrollment to the end of treatment at 2 yearsSecondary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 2 years2
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.
Time frame
From enrollment to the end of treatment at 2 years3
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.
Time frame
From enrollment to the end of treatment at 2 years4
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.
Time frame
From enrollment to the end of treatment at 2 yearsOther outcomes
1
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
Time frame
From enrollment to the end of treatment at 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University First Hospital
Lead sponsor
Peking University Third Hospital
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Source ClinicalTrials.gov