Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia
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
Stage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage IV Chronic Lymphocytic Leukemia
|Study Design:||Allocation: Non-Randomized
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 2016 (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.
|Contact: Shuo Ma, MDemail@example.com|
|Contact: Study Coordinatorfirstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Shuo Ma 312-695-6180 email@example.com|
|Principal Investigator: Shuo Ma|
|Karolinska University Hospital Solna||Recruiting|
|Contact: Jeanette Lundin, MD, PhD +46 8 517 75508 firstname.lastname@example.org|
|Principal Investigator: Jeanette Lundin, MD, PhD|
|Principal Investigator:||Shuo Ma, MD, PhD||Northwestern University|