Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM

• Status: Terminated
• Trial end date: 2010-12-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the safety and maximum tolerated dose (MTD) of ALXN6000 (samalizumab) in treating relapsing or refractory B-cell chronic lymphocytic leukemia (B-CLL) or multiple myeloma (MM) and to study how samalizumab may help the immune system fight tumors that express CD200.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexion Pharmaceuticals

Criteria

Inclusion Criteria:

• Relapsing or Refractory B-CLL or MM

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

• Anticipated survival of greater than 6 months

• Female participants of childbearing potential must agree to use 2 forms of contraception

• Participants must have a standard indication for treatment of their malignancy

• Is willing and able to give written informed consent prior to any procedure not considered standard of care

Exclusion Criteria:

• Absolute neutrophil count (ANC) < 1000 x 10^9/liter (L)

• Platelet count < 50,000 x 10^9/L

• Pregnant or lactating women

• Prior history of autoimmune hemolysis requiring therapy

• Prior history of immune thrombocytopenia

• Active autoimmune disease requiring immunosuppressive therapy

• Positive Coombs' Test (neither direct or indirect)

• Ongoing corticosteroid treatment equivalent to the mineralocorticoid potency of 10 milligrams (mg) /day of prednisone, or greater, for any condition

• Prior stem cell transplantation within 4 weeks prior to enrollment

• Prior chemotherapy for the applicable malignancy within 30 days of enrollment

• Neurosurgery or cranial radiation therapy within 1 year of enrollment

• Clinically significant renal, hepatic, or cardiopulmonary disease