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Phase II Trial of Ofatumumab and Fresh Frozen Plasma in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia

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Trial Information

Phase II Trial of Ofatumumab and Fresh Frozen Plasma in Patients With Relapsed or Refractory Chronic Lymphocytic 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.


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

- ALT < 2.5 times upper limit of normal (unless due to disease involvement of
liver)

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to therapy

Outcome Description:

Defined as complete, or partial response, and progression-free survival. Measured by National Cancer Institute - Working Group and International Workshop on Chronic Lymphocytic Leukemia

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Joseph Tuscano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis

Authority:

United States: Food and Drug Administration

Study ID:

UCDCC#232

NCT ID:

NCT01716208

Start Date:

January 2013

Completion Date:

January 2016

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Fresh Frozen Plasma
  • Complement
  • Monoclonal Antibody
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

University of California Comprehensive Cancer CenterSacramento, California  95817