Patients With Relapsed or Refractory Diffuse Large B Cell Non Hodgkin Lymphomas

• Status: Terminated
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II open label study that looks at the efficacy and toxicity of Ofatumumab monotherapy in patients with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL). Patients will receive weekly infusions of Ofatumumab of 1000 mg each for 8 weeks (induction phase) followed by continuing the study drugs every other week in subsequent cycles (maintenance phase). Each 4 weeks of therapy will be calculated as one cycle. Treatment will continue until disease progression, toxicity, patient's withdrawal, or investigator's discretion.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncology Specialists, S.C.
• Collaborator: University of Illinois at Chicago
• Treatments: Antibodies, Monoclonal; Ofatumumab

Criteria

Inclusion Criteria:

• Relapsed and/or refractory DLBCL,not HSCT candidates. Pts must have failed standard of care (SOC) therapy w/rituximab plus CHOP or its equivalent & not considered hematopoietic stem cell transplant (HSCT) candidates based on investigator's discretion

• Pts must have measurable disease radiographically on CT and/or PET scans and/or bone marrow biopsy.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

• Age ≥18 years. No upper limit of age

• Life expectancy of 6 months or more based on investigator's best estimate.

• Pts able to read, understand, & sign informed consent

• Evidence of CD20 positivity in treated pts, using flow or immunohistochemistry.

• Pts will be stratified based on bulk of disease (bulk defined as any area w/ more than 5cm in greatest dimension)

• Pts must agree to an acceptable form of birth control

Exclusion Criteria:

• Other histologies of non-Hodgkin's lymphoma (NHL)

• Known central nervous system (CNS) involvement with NHL

• Known HIV positive status

• Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.

• Corticosteroid use is allowed as long as it is for non-lymphoma related causes such as rheumatoid arthritis and chronic obstructive pulmonary disease (COPD).

• Pts w/prior malignancies are allowed as long as they are in remission & their last treatment for such malignancy is 2 years prior to enrollment or more. Pts w/non-melanoma skin cancers that have received adequate therapy prior to enrollment & women w/history of cervical cancers are allowed.

• Significant concurrent uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurologic, cerebral, or psychiatric disease.

• Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per the investigator's assessment).

• Adequate bone marrow function by virtue of having Platelets >50,000/ul & absolute neutrophil count (ANC) >1000/ul is required unless low counts are attributed to diffuse bone marrow infiltration with NHL as documented with a bone marrow biopsy exam.

• Pts with creatinine >2.0 times the upper limit of normal will be excluded unless they have a normal creatinine clearance-estimated or measure 12 or 24 hour creatinine clearance of <60 mL/min

• Pts w/total bilirubin >1.5 times upper limit of normal will be excluded, unless due to DLBCL involvement of liver or a known history of Gilbert's disease.

• Pts with aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/Alkaline phosphatase (Alk Phos) >2.5 times upper limit of normal

• Previous tx with Ofatumumab

• Prior exposure to an investigational agent within 4-weeks from starting Ofatumumab

• History of significant cerebrovascular disease or event w/significant symptoms or sequelae

• Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to randomization, congestive heart failure (NYHA III-IV), & arrhythmia unless controlled by therapy, w/exception of extra systoles or minor conduction abnormalities.

• Positive serology for hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive & regardless of HBsAb status, a HB DNA test will be performed and if positive the subject to be excluded. Note: If HBcAb positive and HBsAb positive, which is indicative of a past infection, subject can be included

• 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 must have a negative pregnancy test at screening, including women whose last menstrual period was less than 1 year prior to screening, unable or unwilling to use adequate contraception from study start to 1 year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.