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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT01073267
Eligibility Criteria:
Inclusion Criteria:
1. Biopsy-confirmed mycosis fungoides in stage IB-IIIA
2. Patients must have failed or have been intolerant to at least one prior systemic or topical therapy which may include topical steroids
3. 18 years of age or older
4. Life expectancy greater than 6 months
5. Eastern Cooperative Oncology Group (ECOG) of \</= 2
6. Adequate bone marrow function: White blood count (WBC) \>/= 2000/uL; platelet count\>/= 100,000/mm3; Absolute neutrophil count (ANC) \>/= 1000
7. Required wash out period for prior therapies (Note: patients with progressive disease may be treated earlier than required washout period per Investigator's decision) a) Topical therapy: 2 weeks, b) Systemic biologic, monoclonal antibody or chemotherapy: 4 weeks, c) Radiotherapy (excluding TSEBT) or phototherapy: 4 weeks, d) Other investigational therapy: 4 weeks
8. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
1. Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study)
2. Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of patient to undergo treatment
3. Prior malignancy (active within 5 years of screening) except completely excised non-invasive basal cell or squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix
4. Pregnant or lactating
5. Initiation or change in dosage of topical corticosteroids within 3 weeks of study treatment (Note: topical steroid use within 3 weeks is allowed provided the strength and use has been stable for at least 1 month; 'prescription strength' topical corticosteroids cannot be started during the study)
6. Any other medical history, including laboratory results, deemed by the Investigator to be likely to interfere with patient participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01073267
Study Brief:
Protocol Section:
NCT01073267