Serum biomarkers for patients with mycosis fungoides, Sézary syndrome and cutaneous B-cell lymphoma during and after treatment

Serum biomarkers for patients with mycosis fungoides, Sézary syndrome and cutaneous B-cell lymphoma during and after treatment - S-MISR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030375

Enrollment

300

Registered

2022-09-27

Start date

2019-08-01

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C82 C83 C84 C85 C86

Interventions

Group 1: Analysis of soluble biomarkers on the first and last day of irradiation, at 4 weeks, 8 weeks, 12 weeks, then every 3 months until progression or relapse.

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Histologically-confirmed diagnosis of primary cutaneous T-cell and B-cell Lymphoma (Mycosis fungoides, Sezary Syndrom, pcALCL, FL, MZL, DLBCL-leg type, others) Insufficient response to at least one prior systemic or topical therapy Age = 18 years Wash-out period of 4 weeks before systemic therapy and 2 weeks before topical therapy Written informed consent for study participation Life expectancy > 6 months Eastern Cooperative Oncology Group score = 2

Exclusion criteria

Exclusion criteria: Prior or active skin malignancy (except for completely excised, non-invasive basal cell or squamous cell carcinoma diagnosed > 2 years prior to enrollment) Uncontrolled bacterial or fungal infection at time of enrollment Active or prior autoimmune disease requiring systemic treatment Active or prior non-infectious pneumonitis requiring steroids or pulmonary fibrosis Pregnancy or lactation; Women of childbearing age with reproductive potential should use adequate birth control measures during the study treatment period and for at least 5 months after treatment. Patients awaiting stem cell transplantation

Design outcomes

Primary

Measure	Time frame
Determine levels and changes in levels of various soluble biomarkers in patients' serum before and after treatment. Changes in lymphocyte subsets, T cell subpopulation, quantitative immunoglobulin	—

Secondary

Measure	Time frame
Overall response rate, progression-free survival, overall survival Patient related endpoints: Dermatology Life Quality Index (DLQI), Skindex-29, Functional Assessment of Cancer Therapy General (FACT-G), EORTC QLQ-C30 and QoL/LoL questionnaires	—

Countries

Germany

Contacts

Public ContactKhaled Elsayad

Universitätsklinikum Marburg

khaled.elsayad@uk-gm.de064215865972

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026