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

Stopped early · Phase 1/Phase 2

Conditions studied: B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00648739

Run by

Alexion Pharmaceuticals, Inc.

People needed

26

Starts

2008-06-19

Expected to finish

2010-12-14

Last updated by the study team

2019-03-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Atlanta, Georgia, United States
• Study site — Morristown, New Jersey, United States
• Study site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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