Primary Cutaneous LymphomaTACTICALNCT05518851
TreAtments and outComes in paTients With prImary CutAneous Lymphoma
An observational study of Primary Cutaneous Lymphoma, run by Peking University First Hospital at 5 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Cutaneous Lymphoma
- How many people
- 3,000 participants
- Where
- 5 sitesChina
- Study dates
- 1 Aug 2022to Aug 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who fail to provide informed consent form.
- Patients who cannot complete the questionnaire independently or under the guidance of investigators.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Chunlei Zhang, MD, zhangchunleius@163.com
- Recruiting
Peking University First Hospital
Beijing
Yang Wang, MD, yangwang_dr@bjmu.edu.cn
- Recruiting
SUN YAI-SEN Memorial Hospital, SUN YAI-SEN University
Guandong, Guangdong, 510235
Fengjie Liu, PhD, liufengjie119@163.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xiangjun Liu, PhD, ql09738@163.com
- Recruiting
Hospital for Skin Disease, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Nanjing, Jiangsu, 210042
Hao Chen, MD, ch76ch@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Cutaneous Lymphoma
- Keywords
- Primary Cutaneous Lymphoma, Treatment, Survival, China, Non-Hodgkin's Lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Lymphoma, Non-Hodgkin
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of significant therapies
The "significant therapies" of primary cutaneous lymphoma includes all topical and systemic therapies, radiotherapy, or phototherapy.
Measured: 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
The "significant therapies" of primary cutaneous lymphoma includes all topical and systemic therapies, radiotherapy, or phototherapy. Recorded as "month".
Measured: 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
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".
Measured: At the each scheduled follow-up visit through study completion, an average of 3 months
Objective response rate(ORR)
Proportion of patients with CR and PR.
Measured: Through study completion, an average of 1 year.
Time-to-next treatment (TTNT)
Date of initiation of primary treatment to date of new significant treatment.
Measured: At the time of treatment change, through study completion, an average of 3 months.
Time to response (TTR)
Date of initiation of treatment to date when criteria for response (PR or CR) first met.
Measured: At the time of response, through study completion, an average of 3 months.
Time to treatment failure (TTF)
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.
Measured: At the time of treatment failure, through study completion, an average of 3 months.
Secondary outcomes (4)
Overall survival (OS)
Date of diagnosis to death from any cause.
Measured: Baseline and at time of occurrence of death, through study completion, an average of 1 year.
Progression Free Survival (PFS)
Date of diagnosis to first date meets criteria for PD or death as a result of any cause
Measured: 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)
Date of diagnosis to death as a result of disease
Measured: Baseline and the time of death due to disease, through study completion, an average of 1 year.
Disease Free Survival (DFS)
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Aug 2022
- Primary completionAug 2032 (estimated)
- Study completionAug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Primary Cutaneous LymphomaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang WANG, Peking University First Hospital
- Investigators
- Yang Wang, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518851
- Sponsor's protocol ID
- PKU2022265
- Acronym
- TACTICAL
- Status last verified
- Nov 2023
- First submitted
- 23 Aug 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 34758074Willemze R, Jaffe ES, Burg G, Cerroni L, Berti E, Swerdlow SH, Ralfkiaer E, Chimenti S, Diaz-Perez JL, Duncan LM, Grange F, Harris NL, Kempf W, Kerl H, Kurrer M, Knobler R, Pimpinelli N, Sander C, Santucci M, Sterry W, Vermeer MH, Wechsler J, Whittaker S, Meijer CJ. WHO-EORTC classification for cutaneous lymphomas. Blood. 2005 May 15;105(10):3768-85. doi: 10.1182/blood-2004-09-3502. Epub 2005 Feb 3.
PubMed 15692063Willemze R, Cerroni L, Kempf W, Berti E, Facchetti F, Swerdlow SH, Jaffe ES. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019 Apr 18;133(16):1703-1714. doi: 10.1182/blood-2018-11-881268. Epub 2019 Jan 11.
PubMed 30635287Olsen E, Vonderheid E, Pimpinelli N, Willemze R, Kim Y, Knobler R, Zackheim H, Duvic M, Estrach T, Lamberg S, Wood G, Dummer R, Ranki A, Burg G, Heald P, Pittelkow M, Bernengo MG, Sterry W, Laroche L, Trautinger F, Whittaker S; ISCL/EORTC. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007 Sep 15;110(6):1713-22. doi: 10.1182/blood-2007-03-055749. Epub 2007 May 31.
PubMed 17540844Jawed SI, Myskowski PL, Horwitz S, Moskowitz A, Querfeld C. Primary cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome): part II. Prognosis, management, and future directions. J Am Acad Dermatol. 2014 Feb;70(2):223.e1-17; quiz 240-2. doi: 10.1016/j.jaad.2013.08.033.
PubMed 24438970Jawed SI, Myskowski PL, Horwitz S, Moskowitz A, Querfeld C. Primary cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome): part I. Diagnosis: clinical and histopathologic features and new molecular and biologic markers. J Am Acad Dermatol. 2014 Feb;70(2):205.e1-16; quiz 221-2. doi: 10.1016/j.jaad.2013.07.049.
PubMed 24438969
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatments and Outcomes in Patients With Primary Cutaneous Lymphoma: a Nationwide Multi-center Prospective Study in China
- ClinicalTrials.gov ID
- NCT05518851
- Acronym / sponsor ID
- TACTICAL / PKU2022265
- Conditions
- Primary Cutaneous Lymphoma
- Keywords
- Primary Cutaneous Lymphoma, Treatment, Survival, China, Non-Hodgkin's Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Aug 2032 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who fail to provide informed consent form.
- Patients who cannot complete the questionnaire independently or under the guidance of investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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".
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".
Objective response rate(ORR)
Time frame: Through study completion, an average of 1 year.
Proportion of patients with CR and PR.
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.
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.
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.
4 secondary outcomes
Overall survival (OS)
Time frame: 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.
Disease Specific Survival (DSS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 34758074Olsen 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.
- Background: PubMed 15692063Willemze R, Jaffe ES, Burg G, Cerroni L, Berti E, Swerdlow SH, Ralfkiaer E, Chimenti S, Diaz-Perez JL, Duncan LM, Grange F, Harris NL, Kempf W, Kerl H, Kurrer M, Knobler R, Pimpinelli N, Sander C, Santucci M, Sterry W, Vermeer MH, Wechsler J, Whittaker S, Meijer CJ. WHO-EORTC classification for cutaneous lymphomas. Blood. 2005 May 15;105(10):3768-85. doi: 10.1182/blood-2004-09-3502. Epub 2005 Feb 3.
- Background: PubMed 30635287Willemze R, Cerroni L, Kempf W, Berti E, Facchetti F, Swerdlow SH, Jaffe ES. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019 Apr 18;133(16):1703-1714. doi: 10.1182/blood-2018-11-881268. Epub 2019 Jan 11.
- Background: PubMed 17540844Olsen E, Vonderheid E, Pimpinelli N, Willemze R, Kim Y, Knobler R, Zackheim H, Duvic M, Estrach T, Lamberg S, Wood G, Dummer R, Ranki A, Burg G, Heald P, Pittelkow M, Bernengo MG, Sterry W, Laroche L, Trautinger F, Whittaker S; ISCL/EORTC. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007 Sep 15;110(6):1713-22. doi: 10.1182/blood-2007-03-055749. Epub 2007 May 31.
- Background: PubMed 24438970Jawed SI, Myskowski PL, Horwitz S, Moskowitz A, Querfeld C. Primary cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome): part II. Prognosis, management, and future directions. J Am Acad Dermatol. 2014 Feb;70(2):223.e1-17; quiz 240-2. doi: 10.1016/j.jaad.2013.08.033.
- Background: PubMed 24438969Jawed SI, Myskowski PL, Horwitz S, Moskowitz A, Querfeld C. Primary cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome): part I. Diagnosis: clinical and histopathologic features and new molecular and biologic markers. J Am Acad Dermatol. 2014 Feb;70(2):205.e1-16; quiz 221-2. doi: 10.1016/j.jaad.2013.07.049.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yang Wang, MD principal investigator
Peking University First Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Cutaneous Lymphoma, run by Peking University First Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Wang, MD ((86)-10-83572350, yangwang_dr@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05518851, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.