Serum biomarkers for mycosis fungoidesm, Sézary syndrome, and cutaneous B cell lymphoma patients during and after treatments

Recruiting

Conditions: C82
C83
C84
C85
C86
Follicular lymphoma
Non-follicular lymphoma
Mature T/NK-cell lymphomas
Other and unspecified types of non-Hodgkin lymphoma
Other specified types of T/NK-cell lymphoma

Registration Number: DRKS00030375

Lead Sponsor: niversitätsklinikum Münster

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 130

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

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the concentration and change in the concentration of various soluble biomarkers in the serum of patients before and after treatments. Changes of lymphocyte subsets, T-cell subpopulation, quantitative immunoglobulin<br>

Secondary Outcome Measures

Name	Time	Method
Overall response rate, Progression-free survival, Overall survival<br>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