Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT01645293
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent, prior to pre-study screening and treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice, ability to understand the written informed consent document.
* Male or female \> 18 years of age to 70 years of age
* Diagnosis of primary cutaneous CD30+ large T cell lymphoma OR
* Diagnosis of transformed CD30+ mycosis fungoides, i.e.,
* Histological confirmation of diagnosis.
* multiple (\> 5) cutaneous tumor lesions (TNM EORTC 2007 T3, N1, clinical stage \<IIb),
* Measurable disease according to RECIST criteria
* Refractory or relapsed disease after at least one line of treatment, e.g. PUVA (Psoralen plus UVA), PUVA + Interferon, oral Bexarotene, low dose MTX)
* ECOG performance status 0-3
* Life expectancy \> 12 months
* Female patients with childbearing potential must have a negative serum pregnancy test within two weeks of first dose of study drug. Male and female patients must agree to use an effective oral contraceptive method while on study treatment, if appropriate, and for a minimum of twelve months following study therapy
Exclusion Criteria:
* Previously untreated patients
* Presence of any organ or brain involvement as determined during tumor staging by contrast computed tomography \[CT\] or magnetic resonance imaging \[MRI\] scan
* Known hereditary blood coagulation disorders/DIC
* Prior allogeneic hematopoietic stem-cell or organ transplantation
* Severe cardiovascular disease like functionally restricting heart rhythm disturbance or heart malformation or severe hypertension, or cardiac insufficiency \> NHYA-II
* known active infection including HIV, Hepatitis B or C, VZV, or CMV
* Insufficient bone marrow reserve (Leucocytes \<3.500/μl; Thrombocytes \<100.000/μl)
* Creatinine-Clearance \< 50 ml/min or Crea \> 1.8 mg/dl
* Bilirubin \> 2 mg/dl; ASAT, ALAT \> 2.5xN
* Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
* Known pulmonary dysfunction
* Requirement of chronic immune suppression
* Treatment with corticosteroids for concomitant or intercurrent disease
* Having participated in another clinical trial or any IND in the preceding 4 weeks
* Anti-cancer chemotherapy in the preceding 4 weeks
* Known drug abuse/alcohol abuse
* Known allergic/hypersensitivity reaction to any of the components of the treatment
* Known serious uncontrolled infections
* Known active secondary malignancy or other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the skin or cervix
* Medical or psychological condition or inadequate knowledge of german language which in the opinion of the investigator would not permit the patient to complete the study or meaningfully sign informed consent
* Legal incapacity or limited legal capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01645293
Study Brief:
Protocol Section:
NCT01645293