Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia
NCT01361711 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2025-05-23
Summary
This phase II trial studies the side effects and how well giving alemtuzumab and ofatumumab together works in treating patients with previously untreated chronic lymphocytic leukemia (CLL). Monoclonal antibodies, such as alemtuzumab and ofatumumab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Giving alemtuzumab together with ofatumumab may kill more cancer cells
Conditions
- Stage I Chronic Lymphocytic Leukemia
- Stage II Chronic Lymphocytic Leukemia
- Stage III Chronic Lymphocytic Leukemia
- Stage IV Chronic Lymphocytic Leukemia
Interventions
- BIOLOGICAL
-
alemtuzumab
Given SC
- BIOLOGICAL
-
ofatumumab
Given IV
- PROCEDURE
-
biopsy
Correlative studies
Sponsors & Collaborators
- collaborator INDUSTRY
-
National Comprehensive Cancer Network
collaborator NETWORK - lead OTHER
Principal Investigators
-
Shuo Ma, MD, PhD · Northwestern University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-06-30
- Primary Completion
- 2015-08-17
- Completion
- 2027-05-31
Countries
- United States
- Sweden
Study Locations
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