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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT00066469
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed post-transplant lymphoproliferative disease (PTLD)
* Presents with 1 of the following:
* Fulminant PTLD (F-PTLD)
* Fever greater than 38°C
* Hypotensive (for age)
* Evidence of multiple organ involvement/failure, including at least 2 of the following:
* Marrow (including pancytopenia without detectable B-cell proliferation)
* Liver (coagulopathy, transaminitis, and/or hyperbilirubinemia)
* Lungs (interstitial pneumonitis with or without pleural effusions)
* Gastrointestinal tract hemorrhage
* Non-fulminant PTLD (NF-PTLD)
* Does not meet the above F-PTLD criteria
* Considered medically refractory to reduced immune suppression (50% or more reduction of immunosuppression) for at least 1 week
* CD20 positive AND Epstein-Barr virus positive
* Must have received prior solid organ transplantation
* Must have residual disease after biopsy and/or surgery
* No PTLD central nervous system (CNS) disease, defined as positive cytology and/or radiographic evidence
PATIENT CHARACTERISTICS:
Age
* Under 31
Performance status
* Not specified
Life expectancy
* NF-PTLD patients:
* At least 8 weeks
Hematopoietic
* See Disease Characteristics
Hepatic
* See Disease Characteristics
Renal
* Not specified
Pulmonary
* See Disease Characteristics
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 1 month since prior rituximab
Chemotherapy
* More than 4 weeks since prior chemotherapy and recovered
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Years
Study:
NCT00066469
Study Brief:
Protocol Section:
NCT00066469