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A Phase I Study of Subcutaneous Ocaratuzumab (Fab- and Fc-engineered Anti-CD20 Monoclonal Antibody) in Patients With Previously Treated CD20+ B-Cell Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Previously Treated CD20+ B-cell Malignancies

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Trial Information

A Phase I Study of Subcutaneous Ocaratuzumab (Fab- and Fc-engineered Anti-CD20 Monoclonal Antibody) in Patients With Previously Treated CD20+ B-Cell Malignancies


Inclusion Criteria:



- Age >18 years;

- Histologically confirmed diagnosis of a CD20+ B-cell malignancy;

- Received at least one prior treatment regimen;historically documented
CD20-positivity is acceptable;

- Appropriate for single agent study drug therapy as prescribed by this protocol;

- ECOG performance status 0 to 2;

- Adequate hematopoietic, renal, and hepatic functions defined as:

- Absolute neutrophil count greater than 1000 /mm³

- Platelet count greater than 75,000/mm³

- Hemoglobin greater than 8.5 g/dL

- Serum creatinine ≤ 1.5x upper limit of normal

- AST, ALT, and total bilirubin ≤ 3x upper limit of normal;

- Ability to understand and the willingness to sign a written informed consent
document;

- Life expectancy of 6 months or greater.

Exclusion Criteria:

- Anti-CD20 therapy within 4 weeks of enrollment;

- Systemic chemotherapy or immunotherapy within 14 days of enrollment;

- Chronic systemic steroid therapy defined as prednisone or equivalent 10 mg/day or
greater;

- Systemic cytotoxic or immunosuppressive therapy to be administered concomitantly
while participating on this study;

- Active infection, chronic or severe infection requiring ongoing antimicrobial
therapy.

- Positivity for hepatitis B (defined as HepBs Antigen +), hepatitis C (defined as
HepC Antibody +), or HIV; HIV positive patients on antiretroviral therapy will be
excluded;

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition;

- Significant cardiac disease (New York Heart Association classes III or IV) or
unstable angina despite medication;

- Women who are pregnant or breast-feeding;

- Women of child bearing potential who are unwilling to use effective contraception for
the duration of the study drug administration and 6 months after final dose of drug
is administered;

- Psychiatric illness/social situations that would limit compliance with study
requirements;

- Participation in other investigational studies while enrolled on this trial.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetic parameters following SC ocaratuzumab administration such as area under the curve, maximum serum drug concentration, and elimination half life

Outcome Time Frame:

Every office visit throughout the study for up to 12 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MEN-001

NCT ID:

NCT01858181

Start Date:

August 2013

Completion Date:

Related Keywords:

  • Previously Treated CD20+ B-cell Malignancies
  • Neoplasms

Name

Location

Universtity of Texas Southwestern Medical CenterDallas, Texas  75390