Status:
COMPLETED
A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
MedImmune LLC
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible fo...
Eligibility Criteria
Inclusion
- Histologically confirmed B-cell Chronic Lymphocytic Leukemia (CLL) according to the National Cancer Institute criteria; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; Adequate hematological function
Exclusion
- Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational, or hormonal therapy for treatment of lymphoma within 28 days prior to treatment;
- Exposure to bendamustine within the 180 days before study enrollment
- Prior autologous or allogeneic stem cell transplantation (SCT);
- Clinically significant abnormality on electrocardiogram (ECG) as determined by the treating physician or medical monitor;
- History of other invasive malignancy within 5 years except for localized/in situ carcinomas;
- Evidence of active infection, Confirmed current central nervous system involvement by leukemia or lymphoma;
Key Trial Info
Start Date :
February 7 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2016
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT01466153
Start Date
February 7 2012
End Date
January 8 2016
Last Update
May 31 2017
Active Locations (54)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Burbank, California, United States
3
Research Site
La Jolla, California, United States
4
Research Site
Palm Springs, California, United States