Alemtuzumab + Ofatumumab for CLL
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but prior cytotoxic therapies are not allowed, except for certain corticosteroids which must be stopped at least one week before joining the study.
Is the combination of Alemtuzumab and Ofatumumab generally safe for humans?
How is the drug combination of Alemtuzumab and Ofatumumab unique for treating CLL?
The combination of Alemtuzumab and Ofatumumab is unique for treating chronic lymphocytic leukemia (CLL) because it targets two different antigens on cancer cells, CD52 and CD20, potentially offering a more comprehensive attack on the cancer cells. This dual-target approach may be beneficial for patients who are resistant to other treatments, as each drug has shown effectiveness in difficult-to-treat cases of CLL.678910
What data supports the effectiveness of the drug combination Alemtuzumab and Ofatumumab for treating chronic lymphocytic leukemia (CLL)?
Alemtuzumab has shown effectiveness in treating chronic lymphocytic leukemia (CLL), with better response rates and progression-free survival compared to chlorambucil in untreated patients. Ofatumumab has been effective as a single-agent therapy in patients with CLL who are resistant to other treatments, indicating its potential benefit in combination with Alemtuzumab.678911
Who Is on the Research Team?
Shuo Ma
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
This trial is for adults with untreated chronic lymphocytic leukemia (CLL) who need treatment due to symptoms or blood abnormalities. They must be in good enough health to participate, not have other active cancers except certain skin cancers or localized breast/cervical cancer, and can't have serious heart conditions, hepatitis B or C, HIV, recent strokes, or uncontrolled medical issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive alemtuzumab subcutaneously three times a week for 18 weeks and ofatumumab intravenously on specific weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Alemtuzumab
- Biopsy
- Ofatumumab
Alemtuzumab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
National Comprehensive Cancer Network
Collaborator