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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT01027702
Eligibility Criteria:
Inclusion Criteria:
* Patients must have been treated on the LCH BMT 09-01 protocol
* Signed informed consent by patient or legal guardian
Exclusion Criteria:
* Active GVHD at the time when DLI are due
* History of acute GVHD \> grade I prior to DLI
* Disease due to viral infection (eg. CMV) when DLI are due (asymptomatic viral replication or viral shedding is not a contraindication)
* Uncontrolled bacterial or fungal infection
* O2 saturation by pulse oximetry \< 95%
* Bilirubin \> 3mg/dL or ALT \> 5 x upper limit of normal
* Creatinine \> 3x baseline (at transplant)
* ANC (WBC x % neutrophils + bands) \< 500/ul
* Significant effusions (eg. pleural or pericardial) or ascites
* EBV-related PTLD
* Persistent or increasing mixed chimerism requiring therapeutic DLI as defined on the LCH BMT 09-01 protocol
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Years
Study:
NCT01027702
Study Brief:
Protocol Section:
NCT01027702