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:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT03742804
Eligibility Criteria:
Inclusion Criteria:
1. Cutaneous T-cell lymphoma with persistent, relapsed or refractory disease following at least two prior therapies including at least one systemic therapy. Patients with aggressively progressing disease as per the investigator's assessment are not eligible.
2. Skin lesions accessible for intratumoral injection and at least one additional site of disease outside the radiation field for assessment of distal (abscopal) response.
3. ≥ 18 years of age.
4. Life expectancy of ≥ 6 months per the investigator.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Electrocardiogram (ECG) without evidence of clinically significant ischemia or arrhythmia
7. If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use two methods of birth control or is considered highly unlikely to conceive during the dosing period and for three months after last study treatment.
8. If male and sexually active with a FCBP, must agree to use effective contraception such as latex condom or is sterile (e.g. following a surgical procedure) during the dosing period and for three months after last study treatment.
Exclusion Criteria:
1. Cancer therapies, including chemotherapy, radiation (non-study regimen related), within 4 weeks prior to the first scheduled G100 dose; histone deacetylase (HDAC) inhibitors and retinoids or interferon (IFN) or methotrexate or extracorporeal photopheresis (ECP) within 2 weeks
2. Investigational therapy within 4 weeks prior to G100 dosing
3. Inadequate organ function including:
1. Marrow: Peripheral blood leukocyte count (WBC) \< 3000/(cubic millimeter)mm3, absolute neutrophil count ≤ 1000/mm3, platelets \< 100,000/mm3, or hemoglobin \< 10 grams per deciliter (gm/dL).
2. Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST)\> 2.5 x upper limit of normal (ULN), total serum bilirubin \> 1.5 x ULN (patients withGilbert's Disease may be included if their total bilirubin is ≤3.0 (milligram) mg/dL)
3. Renal: Serum creatinine ≤2 mg/dL
4. Significant immunosuppression from:
1. Concurrent, recent (≤ 4 weeks ago) or anticipated treatment with systemic corticosteroids greater than a maintenance dose for adrenal insufficiency (10 mg daily)
2. Other immunosuppressive medications (e.g.,methotrexate, cyclosporine, azathioprine)
5. Pregnant or nursing
6. Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New YorkHeart Association (NYHA) Grade III or IV heart failure
7. History of other cancer within 2 years (except non-melanoma cutaneous malignancies, treated prostate cancer and cervical carcinoma in situ). Chronic lymphocytic leukemia (CLL) or low grade B-cell lymphoma will be considered on a case-by-case basis.
8. Recent (\< 1 week ago) clinically significant infection or active tuberculosis or evidence of active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
9. Central nervous system involvement with lymphoma, including parenchymal and leptomeningeal disease.
10. Significant autoimmune disease with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or were transient and have completely resolved and require no ongoing therapy.
11. Psychiatric, other medical illness or other condition that in the opinion of the principal investigator prevents compliance with study procedures or ability to provide valid informed consent.
12. History of significant adverse or allergic reaction to any component of G100 trial regimens.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03742804
Study Brief:
Protocol Section:
NCT03742804