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This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.
Milatuzumab (hLL1, IMMU-115), a humanized anti-CD74 monoclonal antibody. Dose escalation will utilize 4 planned dose regimens with 4.0 or 8.0 mg/kg doses administered intravenously either twice weekly (days 1 and 4) or thrice weekly (days 1, 3 and 5) for 4 consecutive weeks. The four planned dose regimens will be labeled as dose level 1 to 4 corresponding to increasing levels of the total dose of milatuzumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| milatuzumab | Experimental | different doses of hLL1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| milatuzumab | Biological | two or three times a week dosing of hLL1 for a total of 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the anti-CD74 antibody will be evaluated based upon physical examinations, hematology and chemistry laboratory evaluations and toxicity events | over first 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (to see if the study drug works) in patients with NHL and CLL | over the first 12 weeks, then over up to 2 years | |
| Pharmacokinetics (how the drug is processed by the body) | over the first 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Wegener, MD, PhD | Gilead Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| Georgetown University Hospital Lombardi Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17875789 | Background | Stein R, Mattes MJ, Cardillo TM, Hansen HJ, Chang CH, Burton J, Govindan S, Goldenberg DM. CD74: a new candidate target for the immunotherapy of B-cell neoplasms. Clin Cancer Res. 2007 Sep 15;13(18 Pt 2):5556s-5563s. doi: 10.1158/1078-0432.CCR-07-1167. | |
| 15297317 | Background | Stein R, Qu Z, Cardillo TM, Chen S, Rosario A, Horak ID, Hansen HJ, Goldenberg DM. Antiproliferative activity of a humanized anti-CD74 monoclonal antibody, hLL1, on B-cell malignancies. Blood. 2004 Dec 1;104(12):3705-11. doi: 10.1182/blood-2004-03-0890. Epub 2004 Aug 5. |
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| ID | Term |
|---|---|
| C540932 | milatuzumab |
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| Pharmacodynamics (how the study drug is absorbed by the body)' | over the first 12 weeks, then over 2 years |
| Immunogenicity | over at least first 12 weeks |
| optimal dose | first 12 weeks |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| M. D. Anderson Cancer Center | Orlando | Florida | 32806 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |