Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Stage I Chronic Lymphocytic Leukemia
- Stage II Chronic Lymphocytic Leukemia
- Stage III Chronic Lymphocytic Leukemia
- Stage IV Chronic Lymphocytic Leukemia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
OBJECTIVES: I. To determine the efficacy and safety of alemtuzumab-ofatumumab combination treatment in previously untreated CLL. OUTLINE: Patients receive alemtuzumab subcutaneously (SC) three times a week in weeks 1-18 and ofatumumab intravenously (IV) over 4-6 hours on day 1 of weeks 3, 5, 7, 9, 1...
OBJECTIVES: I. To determine the efficacy and safety of alemtuzumab-ofatumumab combination treatment in previously untreated CLL. OUTLINE: Patients receive alemtuzumab subcutaneously (SC) three times a week in weeks 1-18 and ofatumumab intravenously (IV) over 4-6 hours on day 1 of weeks 3, 5, 7, 9, 11, 13, 15, and 17. After completion of study treatment, patients are followed up for up to 5 years.
Tracking Information
- NCT #
- NCT01361711
- Collaborators
- GlaxoSmithKline
- National Comprehensive Cancer Network
- Investigators
- Principal Investigator: Shuo Ma, MD, PhD Northwestern University