Overview

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