Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|