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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT00441818
Eligibility Criteria:
Inclusion Criteria:
* Histological diagnosis of relapsed or refractory classical HL
* Age \>18 years
* Received and failed potentially curative chemotherapeutic regimens (e.g., ABVD, Stanford V, or BEACOPP)
* Relapsed following autologous bone marrow transplantation (BMT), or are ineligible, or refused BMT
* Completed radiotherapy, chemotherapy, and/or treatment with other investigational agents at least 3 weeks prior to study entry
* Completed autologous BMT (if received) at least 3 months prior to study entry; completed allogeneic BMT (if received); at least 6 months prior to study entry
* Eastern Cooperative Oncology Group (ECOG) status of \<2
* Life expectancy of \>3 months
* Laboratory data:
* Platelet count \>50,000/mm3
* Hemoglobin \>9.0 g/dL (may be maintained by transfusion)
* Absolute neutrophil count \>1000/mm3
* ALT/AST \<2.5 times the upper limit of normal (ULN)
* Total bilirubin \<1.5 times ULN
* Creatinine \<1.5 mg/dL
* Female subjects of childbearing potential must have a negative serum pregnancy test at screening; subjects must agree to use a medically appropriate form of birth control from screening until 6 months after the last dose of study medication
* Ability to provide written informed consent
Exclusion Criteria:
* Any significant diseases (other than HL) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the subject from participating in the study
* History or clinical evidence of cnetral nervous system (CNS) HL
* Received allogeneic BMT
* Received growth factor support or transfusions to achieve hematology entry criteria (platelets, hemoglobin, absolute neutrophil count)
* Major surgery within 4 weeks prior to study entry
* Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation
* Known history of another primary malignancy that has not been in remission for at least 5 years. Non-melanoma skin cancer and cervical carcinoma in situ or squamous intraepithelial lesions (e.g., cervical intraepithelial neoplasia \[CIN\] or prostatic intraepithelial/intraductal neoplasia \[PIN\]) are allowed.
* Any active viral, bacterial, or systemic fungal infection within 4 weeks prior study entry
* Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV)
* Histry of significant chronic or recurrent infections requiring treatment
* Receiving systemic steroids exceeding 10 mg prednisone or equivalent, or unstable on steroid medication, during the 3 weeks immediately preceding enrollment
* Pregnant or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00441818
Study Brief:
Protocol Section:
NCT00441818