Phase I/II Study of Different Doses and Dose Schedules of Milatuzumab (hLL1) in CLL
Completed · Phase 1/Phase 2
Conditions studied: Chronic Lymphocytic Lymphoma
In brief
This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.
Key facts
- Study ID
- NCT00603668
- Run by
- Gilead Sciences
- People needed
- 19
- Starts
- 2008-08-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2021-08-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
- Georgetown University Hospital Lombardi Cancer Center — Washington D.C., District of Columbia, United States
- M. D. Anderson Cancer Center — Orlando, Florida, United States
- University of Pennsylvania Cancer Center — Philadelphia, Pennsylvania, United States
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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