C84
Conditions
Interventions
Group 1: Radiotherapy followed by pegylated interferon alpha-2a
Group 2: Radiotherapy alone
Sponsors
Universitätsklinikum Münster
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: •Histologically confirmed diagnosis of MF stage IB-IV •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 to minimize latent clinical benefit or residual toxicity related to prior treatment •Written informed consent for study participation •Life expectancy > 6 months •Eastern Cooperative Oncology Group score = 2 •Adequate bone marrow function: white blood count = 3000/uL; platelet count = 100,000/mm3; hemoglobin =10 g/dL •Estimated creatinine clearance > 40 mL/min. •Aspartate aminotransferase or alanine aminotransferase value less than 2 times the upper limit of normal •Serum total bilirubin < 1.5 times the upper limit of normal
Exclusion criteria
Exclusion criteria: •Prior TSEB course. Localized radiotherapy must have ended at least 4 weeks prior to study enrollment. •Serious illness or medical history that would impair the patient’s ability to undergo radioimmunotherapy. •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) Progression-free survival rate (PFS) Time to next treatment (TTNT) | — |
Countries
Germany
Contacts
Public ContactKhaled Elsayad
Universitätsklinikum Münster
Outcome results
None listed