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 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT00539695
Eligibility Criteria:
INCLUSION CRITERIA:
INCLUSION CRITERIA FOR INITIAL STUDY ENROLLMENT:
Patients will be eligible for initial enrollment on this study as long as they meet the following criteria:
* Diagnosis of acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, myeloproliferative disorder, Hodgkin lymphoma, non-Hodgkin lymphoma or non-malignant disease requiring allogeneic HSCT
* Birth to age 70 years of age
* Study entry consent is signed and faxed to Research Coordinator
INCLUSION CRITERIA AT TIME OF IL-2 ADMINISTRATION:
* At least day +7 post transplant
* Less than or equal to 30 days post transplant
* Lansky or Karnofsky score greater than or equal to 50%
* Total bilirubin less than or equal to 1.5mg/dL
* Alanine aminotransferase level (ALT) less than or equal to five times normal, serum direct bilirubin less than or equal to 1.5mg/dL, albumin greater than or equal to 3.0gm/dL
* Serum creatinine less than three times normal or creatinine clearance greater than 80mg/min/1.73m2
* Ensure that informed consent signed and faxed to Research Coordinator
EXCLUSION CRITERIA:
EXCLUSION CRITERIA AT TIME OF IL-2 ADMINISTRATION:
Patients will be ineligible to receive IL-2 injections if any of the following is true:
* Active, acute GVHD greater than or equal to grade II
* Serious, active bacterial, fungal or viral infection (i.e. intensive care)
* Clinical Signs of severe pulmonary dysfunction
* Clinical Signs of sever cardiac dysfunction
* Receiving corticosteroids as GVHD treatment
* Hypersensitivity or allergy to IL-2
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
70 Years
Study:
NCT00539695
Study Brief:
Protocol Section:
NCT00539695