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

NCT01078922 | Terminated Phase 2 Results

• 1 other identifier: OFT113588 (0908)
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Non-Hodgkin Lymphomas

Keywords

ofatumumab diffuse B cell non hodgkins lymphoma DLBCL; refractory DLBCL; relapsed DLBCL

Outcome Measures

Primary Outcomes (1)

• Overall Response (OR)

  OR = # of patients with a Complete Response (CR) plus # of patients with a Partial Response (PR) divided by the total # of evaluable patients. A CR is defined as: 1. Disappearance of all disease. 2. If nodal masses that Positron Emission Tomography (PET)- positive prior to therapy; they must be PET negative 3. If the nodal masses were Variably or PET negative; they must regress to normal. 4. No palpable liver or spleen 5. Palpable nodal masses are no longer palpable 6. Negative bone marrow biopsy A PR is defined as: 1. Regression of measurable disease and no new sites of disease. 2. \> 50% decrease in Sum of Product of Diameters (SPD) of up to 6 largest masses with no increase in the size of other nodes. If the nodal masses were PET positive prior to therapy then PET positive at previously involved sites is allowed. If they were Variably or PET negative then regression on CT is required. 3. No increase in the size of the liver or spleen

  evaluated every 2 months up to 80 weeks

Secondary Outcomes (1)

• Overall Clinical Benefit (OCB)

  Evaluated every 2 cycles (every 2 months), up to 80 weeks

Study Arms (1)

Ofatumumab

EXPERIMENTAL

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

Interventions

Ofatumumab DRUG

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.

Also known as: OFT113588

Ofatumumab

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncology Specialists, S.C.: lead
• University of Illinois at Chicago: collaborator

Study Sites (3)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Oncology Specialists, S.C

Niles, Illinois, 60714, United States

Location

Oncology Specialists, S.C.

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Interventions

ofatumumab

Results Point of Contact

• Title: Research Manager
• Organization: Oncology Specialists, SC

ktolzien@oncmed.net

847-410-0658

Study Officials

• Chadi Nabhan, MD

  Oncology Specialists, S.C.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: March 2, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 16, 2014
• Results First Posted: May 2, 2014

Record last verified: 2014-07

Locations

US (3)