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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT00846833
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed metastatic or relapsed malignant melanoma
* Patients who received prior chemotherapy or immunotherapy
* Patients who have at least one haploidentical donor willing to donate
* ECOG performance status 0 or 1
* 18 - 75 years
* At least one measurable disease according to the RECIST criteria
* Patients with 45% or more left ventricular ejection fraction
* Patients with 50% or more predicted DLCO
* Adequate bone marrow function: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; and hemoglobin ≥ 9 g/dL
* Adequate liver function: total bilirubin ≤ 1.0 x upper limit of the normal range (ULN); AST/ALT ≤ 2.5 x ULN; and alkaline phosphatase ≤ 2.5 x ULN
* Adequate renal function: serum creatinine ≤ 1.0 x ULN or creatinine clearance ≥ 60 mL/min/1.73m2
* At least 3 months of expected survival
* Patients who signed informed consent
Exclusion Criteria:
* Patients who received other chemotherapeutic agents within 30 days prior to study enrollment
* Patients who received adoptive cell therapy including hematopoietic stem cell transplantation
* Patients infected with HIV, HBV, or HCV
* Hypersensitivity to cyclophosphamide or interleukin-2
* Patients who received organ transplantation
* Patients who had arrhythmia or ischemic heart disease
* Pregnant or lactating women
* Patients with uncontrolled infection who did not respond to appropriate antimicrobial agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00846833
Study Brief:
Protocol Section:
NCT00846833