Clinical trial NCT05518851: TreAtments and outComes in paTients With prImary CutAneous Lymphoma
Official title: Treatments and Outcomes in Patients With Primary Cutaneous Lymphoma: a Nationwide Multi-center Prospective Study in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Cutaneous Lymphoma
Keywords: Primary Cutaneous Lymphoma
Treatment
Survival
China
Non-Hodgkin's Lymphoma
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Type of significant therapies
timeFrame: At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months
measure: Duration of significant therapies
timeFrame: At time of initiation of first significant treatment and at the each scheduled follow-up visit, through study completion, an average of 3 months
measure: Clinical response to significant therapies
timeFrame: At the each scheduled follow-up visit through study completion, an average of 3 months
measure: Objective response rate(ORR)
timeFrame: Through study completion, an average of 1 year.
measure: Time-to-next treatment (TTNT)
timeFrame: At the time of treatment change, through study completion, an average of 3 months.
measure: Time to response (TTR)
timeFrame: At the time of response, through study completion, an average of 3 months.
measure: Time to treatment failure (TTF)
timeFrame: At the time of treatment failure, through study completion, an average of 3 months.
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Baseline and at time of occurrence of death, through study completion, an average of 1 year.
measure: Progression Free Survival (PFS)
timeFrame: Baseline and the time of occurrence of PD or death as a result of any cause, through study completion, an average of 1 year.
measure: Disease Specific Survival (DSS)
timeFrame: Baseline and the time of death due to disease, through study completion, an average of 1 year.
measure: Disease Free Survival (DFS)
timeFrame: 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.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Guandong
country: China
facility: SUN YAI-SEN Memorial Hospital, SUN YAI-SEN University
state: Guangdong
city: Nanjing
country: China
facility: Hospital for Skin Disease, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
state: Jiangsu
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Peking University First Hospital
name: Yang Wang, MD
role: PRINCIPAL_INVESTIGATOR
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.
citation: Willemze 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.
citation: Willemze 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.
citation: Olsen 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.
citation: Jawed 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.
citation: Jawed 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.