Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT01361711|
Recruitment Status : Active, not recruiting
First Posted : May 27, 2011
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia Stage III Chronic Lymphocytic Leukemia Stage IV Chronic Lymphocytic Leukemia||Biological: alemtuzumab Biological: ofatumumab Procedure: biopsy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of Alemtuzumab-Ofatumumab Combination in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2020|
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
- Response rates [ Time Frame: At 2 months after treatment completion ]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 ]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 ]
- Correlation of disease characteristics with disease outcomes [ Time Frame: At baseline and over 18 weeks ]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 ]Response and survival rates will be compared between the two studies.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361711
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Karolinska University Hospital Solna|
|Principal Investigator:||Shuo Ma, MD, PhD||Northwestern University|