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 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT00284804
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Hodgkin's disease \[HD\] (excluding HIV-associated HD)
* Patients must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
* Patients must have failed or relapsed following second line (i.e., salvage) chemotherapy or relapsed or failed following autologous stem cell transplant
* ECOG Performance Status of 0-2
* Patients must have bi-measurable disease
* At least 4 weeks since the last chemotherapy or radiation therapy with clinical evidence of recovery from any toxicity associated with such treatment
* Life expectancy 12 weeks or greater
* Screening laboratory values must be met
* Patients on corticosteroids must be tapered off the medication 2 weeks prior to study drug administration and remain off corticosteroids until study completion.
Exclusion Criteria:
* Previous treatment with any anti-CD30 antibody
* History of allogeneic transplant
* Any tumor lesion 10cm or greater in diameter
* Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.
* Any significant active or chronic infection
* Apparent active or latent tuberculosis (TB) infection
* Patients who are pregnant or nursing
* Any underlying medical condition which, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events
* Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics, or radiation therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00284804
Study Brief:
Protocol Section:
NCT00284804