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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier:
NCT01078922
First received: February 23, 2010
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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 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.


Condition Intervention Phase
Non-Hodgkin Lymphomas
Drug: Ofatumumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open-label Study of Single Agent Ofatumumab in Patients With Relapsed and/or Refractory Diffuse Large B Cell Non Hodgkin Lymphomas

Resource links provided by NLM:


Further study details as provided by Oncology Specialists, S.C.:

Primary Outcome Measures:
  • overall response [ Time Frame: evaluated every 2 months ] [ Designated as safety issue: No ]
    response is evaluated every other cycle, every two months.


Secondary Outcome Measures:
  • toxicities and side effects [ Time Frame: start of study drug, minimum of 6 months after last dose ] [ Designated as safety issue: Yes ]
    Toxicities and side effects of Ofatumumab assessed based on the NCI common toxicity criteria version 4.0. Most toxicities are likely infusion-related but evaluating other possible adverse events in this patient population is important. Recording baseline symptoms would distinguish disease-related symptoms versus drug-related adverse events.


Estimated Enrollment: 29
Study Start Date: February 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ofatumumab
The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
Drug: Ofatumumab
The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
Other Name: OFT113588

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsed and/or refractory DLBCL,not HSCT candidates. Pts must have failed SOC therapy w/rituximab plus CHOP or its equivalent & not considered HSCT candidates based on investigator's discretion
  • Pts must have measurable disease radiographically on CT and/or PET scans and/or bone marrow biopsy.
  • 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 NHL
  • Known 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 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 & 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 AST/ALT/AlkPhos >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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078922

Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Oncology Specialists, S.C
Niles, Illinois, United States, 60714
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Oncology Specialists, S.C.
University of Illinois at Chicago
Investigators
Principal Investigator: Chadi Nabhan, MD Oncology Specialists, S.C.
  More Information

No publications provided

Responsible Party: Dr. Sigrun Hallmeyer, Principal Investigator, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT01078922     History of Changes
Other Study ID Numbers: OFT113588 (0908)
Study First Received: February 23, 2010
Last Updated: August 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Oncology Specialists, S.C.:
ofatumumab diffuse B cell non hodgkins lymphoma DLBCL
refractory DLBCL
relapsed DLBCL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014