Treatment of patients with cutaneous T-Zell Lymphom

Phase 1

• Conditions: Cutaneous T cell lymphoma; MedDRA version: 20.0Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndromeSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-000924-11-DE
• Lead Sponsor: Ruprecht-Karls-University Heidelberg, Medical Faculty Mannheim represented by the chancellor

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-13
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Histopathologically confirmed Mycosis fungoides or Sézary syndrome (CTCL stage = Ib according to EORTC-ISCL consensus classification2) at study entry with progressive, persistant or recurrent disease
• Pretreatment with topical steroid and/or local PUVA, if the prior therapy is not possible anymore or if there is unsatisfactory response to PUVA or local steroid respectively. Patients with history of first line systemic treatment (interferone or bexarotene) may be included in the study too
• Karnofsky index =70 % (according to Karnofsky DA, Burchenal JH. (1949). The Clinical Evaluation of Chemotherapeutic Agents in Cancer. In: MacLeod CM (Ed), Evaluation of Chemotherapeutic Agents. Columbia Univ Press. Page 196)
• Life expectancy > 3 months
• Age = 18 years
• Adequate organ function:
• differential blood count: hemoglobin = 10 g/dl without transfusions, leukocyte count > 3000/µl, lymphocyte count > 700/µl
• liver enzymes = 2 x upper limit of normal (ULN)
• serum creatinine = 1.5 mg/dl or calculate creatinine clearance = 50 ml/min,
• Negative Pregnancy test from blood, agreement for efficient contraception in male and female patients unless infertility is documented (DMF is not approved during pregnancy)
• Ability to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
• written informed consent must be given according to ICH/GCP, and national/local regulations, before patient registration and prior to any study specific procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

• Another active malignant disease with the following exceptions:
• Basal or squamous cell carcinoma of the skin
• In situ carcinoma of the cervix or the skin
• Topical chemotherapy, superficial radiotherapy, photopheresis or systemic CTCL treatment within 28 days before study therapy initiation
• Severe systemic disease or infection at study therapy initiation
• Prior treatment with DMF or simultaneous topical DMF treatment
• Contraindications for treatment with DMF (known hypersensibility to the drug, severe gastrointestinal disease (like ulcerations), Alcohol abuse, other obligately liver- or nephrotoxic medication, known clinically apparent renal or hepatic insufficiency)
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• Participation in other clinical studies within 14 days before study therapy initiation
• Pregnant or lactating patients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified