Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/29/2018 |
| Start Date: | January 2013 |
| End Date: | April 2019 |
Phase II Trial of Ofatumumab and Fresh Frozen Plasma in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
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.
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.
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.
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.
Inclusion Criteria:
- Patients must have a pathological diagnosis of B-cell CLL.
- Patients must have received prior rituximab therapy and must have recovered from all
non-hematologic toxicities. (Previous radiation is allowed as long as patients have
recovered from all treatment related toxicities).
- Patients must meet the following laboratory values:
- Hgb > 9.0 g/dl
- Platelets > 50,000/mm3
- Creatinine < 2.0 times the institutional upper limit of normal
- SGOT/SGPT < 2.5 times the institutional upper limit of normal
- Total Bilirubin <1. 5 times the institutional upper limit of normal
- Alkaline phosphatase <2.5 times upper limit of normal (unless due to disease
involvement of the liver or bone marrow)
- Patients must be at least 18 years of age.
- Patients must have a performance status of 0-2 by ECOG criteria.
- All patients must be informed of the investigational nature of this study and must
sign and give written consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
- Subjects who have current active hepatic or biliary disease.
- Having received rituximab or rituximab-containing therapy within the prior 3 months.
- Treatment with any known therapeutic or experimental therapy within 4 weeks prior to
enrollment, or currently participating in any other interventional clinical study.
- Other past or current malignancy.
- Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months
prior to start of therapy.
- Chronic or current infectious disease requiring systemic antibiotics, antifungal, or
antiviral treatment such as, but not limited to, chronic renal infection, chronic
chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
- History of significant cerebrovascular disease in the past 6 months or ongoing event
with active symptoms or sequelae.
- Known HIV positive.
- Clinically significant cardiac disease including unstable angina, acute myocardial
infarction within six months prior to randomization, congestive heart failure, and
arrhythmia unless controlled by therapy, with the exception of extra systoles or minor
conduction abnormalities.
- Significant concurrent, uncontrolled medical condition including, but not limited to,
renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or
psychiatric disease which in the opinion of the investigator may represent a risk for
the patient.
- Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg.
- Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which
case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the
result.
- Pregnant or lactating women.
- Women of childbearing potential, including women whose last menstrual period was less
than one year prior to screening, unable or unwilling to use adequate contraception
from study start to one year after the last dose of protocol therapy.
- Male subjects unable or unwilling to use adequate contraception methods from study
start to one year after the last dose of protocol therapy.
- Receiving warfarin.
We found this trial at
1
site
Click here to add this to my saved trials
