Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma
It has been shown that many patients with lymphoma or chronic lymphocytic leukemia (CLL)have low levels of complement. Several drugs have been approved by the Food and Drug Administration (FDA) for use in this cancer. However, these drugs are often used as combination therapies which means two or more drugs are part of the treatment. Many people, especially elderly patients, cannot put up with the use of multiple drugs because of the side effects.
The main purpose of this study is to see if patients respond to therapy with human plasma (known as fresh frozen plasma or FFP) and ofatumumab. Another purpose of the study is to find out if this therapy will increase chances of getting rid of leukemia. This study will also look at the levels of complement in your blood. The levels of complement may allow better understanding of whether increasing the levels of complement by giving FFP may help control leukemia.
Chronic Lymphocytic Leukemia
Drug: Ofatumumab + Fresh Frozen Plasma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Ofatumumab and Fresh Frozen Plasma in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia|
- Response to therapy [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Defined as complete, or partial response, and progression-free survival. Measured by National Cancer Institute - Working Group and International Workshop on Chronic Lymphocytic Leukemia
- Toxicity [ Time Frame: Up to two years ] [ Designated as safety issue: Yes ]Toxicities will be graded according to the NCI CTCAE v4.0.
- Overall Survival [ Time Frame: Up to two years ] [ Designated as safety issue: No ]Overall survival wil be measured as the time from start of treatment to the Date of death or the last date the patient was known to be alive
- Complement levels (CH50 and C2 levels) [ Time Frame: Up to two years ] [ Designated as safety issue: No ]Complement CH50 is a blood test that helps us determine whether protein abnormalities and deficiencies in the complement system are responsible for any increase in autoimmune activity. Complement C2 is a protein that in humans is encoded by the C2 gene. The protein encoded by this gene is part of the classical pathway of complement system.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Ofatumumab + Fresh Frozen Plasma
Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).
Drug: Ofatumumab + Fresh Frozen Plasma
Other Name: Azerra
The vast majority of patients with CLL are elderly and often they cannot tolerate standard multi-agent chemotherapeutic or biochemotherapeutic approaches. Based on this, less toxic and more effective treatment options are needed.
Ofatumumab has proven to be effective in patients with relapsed and/or refractory CLL. Previous studies have shown that ofatumumab is more effective than rituximab at activating complement and utilizing complement-dependent cytotoxicity (CDC).
This study will investigate treating relapsed/refractory CLL patients with FFP in combination with ofatumumab. The hypothesis is that patients with CLL have low complement levels and when they get treated with humanized antibodies like rituximab or ofatumumab these levels drop even further. Both these antibodies utilize complement to exert their cytotoxic effect, thus we hypothesize that by replacing complement levels with FFP we can enhance the efficacy of ofatumumab.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716208
|Contact: Corinne Turrell||916-734-3089|
|United States, California|
|University of California Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Clinical Trials Navigator 916-734-3089|
|Principal Investigator:||Joseph Tuscano, MD||University of California, Davis|