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 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT03086395
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed relapsed/refractory post-transplant lymphoproliferative disorder
* Relapsed/refractory disease with at least 1 prior chemotherapy regimen
* Measurable disease ≥1.5 cm
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. ECOG 3 will be permitted if the decline in the performance status is attributed to the lymphoma
* Able to sign the consent form
* Adequate organ function
* bilirubin ≤1.5 times upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN or ≤5 times ULN for patients with document hepatic involvement with lymphoma
* serum creatinine clearance \>50 ml/min
* absolute neutrophil count (ANC) ≥500/μL (unless documented bone marrow involvement with lymphoma)
* hemoglobin \>8 gm/dl
* platelet count ≥50,000/μL (unless documented bone marrow involvement with lymphoma)
Exclusion Criteria:
* Prior treatment with obinutuzumab
* Pregnancy or breast feeding women
* Current active malignancy other than PTLD, requiring active treatment
* Presence of central nervous system (CNS) involvement
* HIV positive patients
* Myocardial infarction within the past 6 months
* Patients with the following medical conditions that could affect their participation in the study:
* any active acute or chronic or uncontrolled infection
* liver disease including history of viral hepatitis B or C, evidence of cirrhosis, chronic active or persistent hepatitis
* a known history of HIV
* symptomatic cardiac disease, including congestive heart failure, coronary artery disease, and arrhythmias
* Current therapy with chemotherapy or investigational agents within 4 weeks of start of study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03086395
Study Brief:
Protocol Section:
NCT03086395