TreAtments and outComes in paTients With prImary CutAneous Lymphoma (TACTICAL)

November 15, 2023 updated by: Yang WANG, Peking University First Hospital

Treatments and Outcomes in Patients With Primary Cutaneous Lymphoma: a Nationwide Multi-center Prospective Study in China

In order to further improve the diagnosis and treatment level of primary cutaneous lymphoma in China, the National Clinical Center for Skin and Immune Diseases established a standardized diagnosis and treatment center for primary cutaneous lymphoma to systematically and effectively understand the current treatment status of patients with primary cutaneous lymphoma, as well as the efficacy and safety of various treatment methods during practices, so as to further improve the diagnosis and treatment level of primary cutaneous lymphoma and help patients with primary cutaneous lymphoma.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Primary cutaneous lymphomas (PCLs) are defined as non-Hodgkin lymphomas presenting in the skin with no evidence of extracutaneous disease at the time of diagnosis. Primary cutaneous lymphomas include a heterogeneous group of cutaneous T-cell lymphomas (CTCLs) and cutaneous B-cell lymphomas (CBCLs). The different types of PCLs have highly characteristic clinical and histologic features, often a completely different clinical behavior and prognosis, and require a different type of treatment. Various studied in terms of the treatment and outcome of patients with different types of PCLs has been conducted in recent years. While the data of Chinese patients with PCLs are limited. Considering the different proportion of PCLs and limited treatment modalities in China, a nationwide multi-center prospective study is designed to summarize the current treatment status and outcome of patients.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
    • Guangdong
      • Guandong, Guangdong, China, 510235
        • Recruiting
        • Sun Yai-sen Memorial Hospital, Sun Yai-sen University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210042
        • Recruiting
        • Hospital for Skin Disease, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This prospective study will span over 10 years from enrollment to follow-up data collection. Recruitment for this study will occur in the medical clinic at each participating site. Patients with primary cutaneous lymphoma will be identified at participating medical units and these patients will be invited to participate in this study. The skin biopsy will be reviewed by at least two pathologists to confirm the diagnosis. After signing the institutional review board (IRB) approved informed consent, patients will be enrolled in the study and all intend data will be collected at baseline and each scheduled follow-up time.

Description

Inclusion Criteria:

  • Patients from the participatin medical centers that has passed the data review of the National Clinical Center for Skin and Immune Diseases.
  • Patients with a definitive pathological diagnosis of primary cutaneous lymphoma by skin biopsy.

Exclusion Criteria:

  • Patients who fail to provide informed consent form.
  • Patients who cannot complete the questionnaire independently or under the guidance of investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of significant therapies
Time Frame: At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months
The "significant therapies" of primary cutaneous lymphoma includes all topical and systemic therapies, radiotherapy, or phototherapy.
At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months
Duration of significant therapies
Time Frame: At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months
The "significant therapies" of primary cutaneous lymphoma includes all topical and systemic therapies, radiotherapy, or phototherapy. Recorded as "month".
At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months
Clinical response to significant therapies
Time Frame: At the each scheduled follow-up visit through study completion, an average of 3 months
Clinical response are assessed by consensus response criteria in PCLs (Olsen, Elise A et al. "Primary cutaneous lymphoma: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC." Blood vol. 140,5 (2022): 419-437. ), recorded as "CR", "PR", "SD" or "PD".
At the each scheduled follow-up visit through study completion, an average of 3 months
Objective response rate(ORR)
Time Frame: Through study completion, an average of 1 year.
Proportion of patients with CR and PR.
Through study completion, an average of 1 year.
Time-to-next treatment (TTNT)
Time Frame: At the time of treatment change, through study completion, an average of 3 months.
Date of initiation of primary treatment to date of new significant treatment.
At the time of treatment change, through study completion, an average of 3 months.
Time to response (TTR)
Time Frame: At the time of response, through study completion, an average of 3 months.
Date of initiation of treatment to date when criteria for response (PR or CR) first met.
At the time of response, through study completion, an average of 3 months.
Time to treatment failure (TTF)
Time Frame: At the time of treatment failure, through study completion, an average of 3 months.
Date of initiation of treatment until abandonment of therapy, causes of abandonment of therapy may include inadequate response to therapy, intolerable side effects or toxicity, disease progression, and patient withdrawal for whatever reason.
At the time of treatment failure, through study completion, an average of 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Baseline and at time of occurrence of death, through study completion, an average of 1 year.
Date of diagnosis to death from any cause.
Baseline and at time of occurrence of death, through study completion, an average of 1 year.
Progression Free Survival (PFS)
Time Frame: Baseline and the time of occurrence of PD or death as a result of any cause, through study completion, an average of 1 year.
Date of diagnosis to first date meets criteria for PD or death as a result of any cause
Baseline and the time of occurrence of PD or death as a result of any cause, through study completion, an average of 1 year.
Disease Specific Survival (DSS)
Time Frame: Baseline and the time of death due to disease, through study completion, an average of 1 year.
Date of diagnosis to death as a result of disease
Baseline and the time of death due to disease, through study completion, an average of 1 year.
Disease Free Survival (DFS)
Time Frame: Date when criteria for CR first met and date when criteria for relapse/recurrence or or death from any cause, through study completion, an average of 1 year.
Date when criteria for CR first met until time of relapse/recurrence (if global CR, recurrence of disease in any one category) or death from any cause
Date when criteria for CR first met and date when criteria for relapse/recurrence or or death from any cause, through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: YANG WANG, MD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

August 1, 2032

Study Completion (Estimated)

August 1, 2032

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 29, 2022

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKU2022265

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe