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 @ 4:22 PM
Ignite Modification Date:
2025-12-24 @ 4:22 PM
NCT ID:
NCT00082966
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed classical Hodgkin's lymphoma
* No bone marrow biopsies or fine needle aspirates as the sole means of diagnosis
* Core biopsies allowed if they contain adequate tissue for primary diagnosis
* The following subtypes are allowed:
* Nodular sclerosis
* Lymphocyte rich
* Mixed cellularity
* Lymphocyte depletion
* Classical Hodgkin's lymphoma, not otherwise specified
* No nodular lymphocyte-predominant Hodgkin's lymphoma
* Relapsed or refractory disease after at least 1 prior standard systemic cytotoxic chemotherapy regimen
* Measurable disease by physical exam or imaging studies
* Any tumor mass \> 1 cm is allowed
* No non-measurable disease only, including the following:
* Bone lesions
* Ascites
* Pleural or pericardial effusion
* Lymphangitis cutis/pulmonis
* Bone marrow
* No curative option available with high-dose therapy and stem cell transplantation
* Performance status - 0-2
* Absolute neutrophil count ≥ 750/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 2.5 times ULN
* Creatinine ≤ 2.5 mg/dL
* No sensory or motor peripheral neuropathy ≥ grade 2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 3 months after study participation
* See Disease Characteristics
* Prior stem cell transplantation allowed
* See Disease Characteristics
* No concurrent chemotherapy
* No concurrent dexamethasone or other steroidal antiemetics
* Concurrent steroids for adrenal failure allowed
* Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed
* Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) is allowed provided other measurable disease is present
* No concurrent palliative radiotherapy
* Recovered from all prior treatment
* No prior bortezomib or other proteosome inhibitors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00082966
Study Brief:
Protocol Section:
NCT00082966