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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT00478959
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed Hodgkin's lymphoma that is relapsed or refractory (repeat biopsy is not mandatory) and is no longer eligible for curative treatment
* \</=3 prior chemotherapy regimens (in patients without a prior ASCT)
* Patients with disease progression after ASCT will be eligible if they have received \</= 1 additional chemotherapy regimen post-ASCT
* ECOG Performance Status 0-2
* Adequate hematological function:
* Absolute granulocyte count \> 1.0 x 10 to the 9/L
* Platelet count \> 75 x 10 to the 9/L
* Adequate renal and hepatic functions:
* Serum creatinine \< 1.25 x UNL or a calculated creatinine clearance \> 50 mL/min
* Serum bilirubin \< 1.5 x UNL and AST/ALT \< 3 x UNL
* Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. Women must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. (See Appendix B Pregnancy Testing Guidelines and Acceptable Birth Control Methods.)
* Able to take aspirin (325 mg daily) as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
* Written Informed Consent must be given according to ICH/GCP and national/local regulations
Exclusion Criteria
* Prior treatment with Lenalidomide or Thalidomide
* Use of any other experimental therapy within the 28 days prior to baseline assessment
* Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C
* Pregnant or Lactating women
* Other significant medical problems such as uncontrolled hypertension, uncontrolled psychiatric symptoms disorders, serious infections, active peptic ulcer disease, or any other medical conditions that might be aggravated by treatment
* Second malignancy in the past five years with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
* Concurrent use of other anti-cancer agents or treatments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00478959
Study Brief:
Protocol Section:
NCT00478959