Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01716208
• Date of registration: 25/10/2012
• Prospective Registration: Yes
• Primary sponsor: Joseph Tuscano
• Public title: Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma
• Scientific title: Phase II Trial of Ofatumumab and Fresh Frozen Plasma in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
• Date of first enrolment: January 2013
• Target sample size: 12
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01716208
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Joseph Tuscano, MD
• Affiliation: University of California, Davis

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Lymphocytic Leukemia

Intervention(s)

Drug: Ofatumumab + Fresh Frozen Plasma

Primary Outcome(s)

Response to therapy [Time Frame: Up to 2 years]

Secondary Outcome(s)

Overall Survival [Time Frame: Up to two years]

Toxicity [Time Frame: Up to two years]

Complement levels (CH50 and C2 levels) [Time Frame: Up to two years]

Secondary ID(s)

UCDCC#232

333961

OFT116066

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline