Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia
Stage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage IV Chronic Lymphocytic Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Trial of Alemtuzumab-Ofatumumab Combination in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia|
- Response rates [ Time Frame: At 2 months after treatment completion ] [ Designated as safety issue: No ]Response rate will be classified as complete remission (CR), partial remission (PR), progressive disease (PD), stable disease (SD), and minimal residual disease (MRD) assessment, as defined by the iwCLL2008 criteria.
- Survival rates [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Survival rates will be calculated for progression-free survival (PFS), therapy-free survival (TFS), and overall survival (OS).
- Treatment toxicity as measured by adverse events experienced while on treatment [ Time Frame: Weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17 ] [ Designated as safety issue: Yes ]
- Correlation of disease characteristics with disease outcomes [ Time Frame: At baseline and over 18 weeks ] [ Designated as safety issue: No ]Clinical outcomes (such as response, PFS and TFS) will be correlated with pre-treatment clinical and biological characteristics(such as Rai staging, presence of bulky lymph nodes, cytogenetics by FISH, CD38, ZAP70 and IgVH mutation status).
- Compare efficacy between this study and historical control study of alemtuzumab-rituximab [ Time Frame: At baseline and over 18 weeks ] [ Designated as safety issue: No ]Response and survival rates will be compared between the two studies.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Experimental: Treatment (monoclonal antibody therapy)
Patients receive alemtuzumab SC three times a week in weeks 1-18 and ofatumumab IV over 4-6 hours on day 1 of weeks 3, 5, 7, 9, 11, 13, 15, and 17.
Other Names:Biological: ofatumumab
Other Names:Procedure: biopsy
Other Name: biopsies
I. To determine the efficacy and safety of alemtuzumab-ofatumumab combination treatment in previously untreated CLL.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361711
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Karolinska University Hospital Solna|
|Principal Investigator:||Shuo Ma, MD, PhD||Northwestern University|