Status:
TERMINATED
Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
B-cell Chronic Lymphocytic Leukemia
Multiple Myeloma
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief 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 mult...
Detailed Description
This was an open-label multicenter study for participants with relapsing or refractory B-CLL or MM. The study was planned to be conducted in 2 parts: Part A and Part B. Both parts were to evaluate saf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 19 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00648739
Start Date
June 19 2008
End Date
December 14 2010
Last Update
March 5 2019
Active Locations (4)
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1
Tucson, Arizona, United States, 85719
2
Atlanta, Georgia, United States, 30322
3
Morristown, New Jersey, United States, 07962
4
Durham, North Carolina, United States, 27710