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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT00603668
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of recurrent chronic lymphocytic leukemia (by NCI criteria)
* Received at least one prior treatment with standard therapy (previous antibody therapy is acceptable)
* Measurable disease (WBC \> 5,000 for CLL)
* See protocol for full list
Exclusion Criteria:
* Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women
* Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last milatuzumab infusion
* Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative;
* Bulky disease by CT, defined as any single mass \>10 cm in its greatest diameter
* Known HIV positive or active hepatitis B or C, or presence of hepatitis B surface antigens or presence of hepatitis C antibody
* Known autoimmune disease or presence of autoimmune phenomena
* At least 7 days beyond any infection requiring antibiotic use.
* Systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, \<20 mg/day, or equivalent) which may continue if unchanged.
* Substance abuse or other concurrent medical or psychiatric conditions that, in the Investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00603668
Study Brief:
Protocol Section:
NCT00603668