Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma

NCT01716208 | Completed Phase 2 Results DMC

• 3 other identifiers: 333961UCDCC#232OFT116066
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Fresh Frozen Plasma; Complement; Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

• Response to Therapy

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

  Up to 37 months.

Secondary Outcomes (3)

• Number of Participants With Toxicities

  Up to two years

• Overall Survival

  Up to two years

• Percent Reduction in Complement Levels (CH50)

  Up to two weeks

Study Arms (1)

Ofatumumab + Fresh Frozen Plasma

EXPERIMENTAL

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

Interventions

Ofatumumab + Fresh Frozen Plasma DRUG

Also known as: Azerra

Ofatumumab + Fresh Frozen Plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joseph Tuscano: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of California Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Analyst
• Organization: University of California, Davis

nlogihara@ucdavis.edu

916-734-8053

Study Officials

• Joseph Tuscano, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: January 14, 2013
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-04

Locations

US (1)