This is a Phase II, single-arm study of ofatumumab investigating the safety of an accelerated infusion schedule of ofatumumab in patients who have received at least one prior therapy for CLL. The primary endpoint is to evaluate the number of subjects able to complete infusion number 3 (2000 mg) within 15 minutes of the planned time.
The purpose of this study is to develop an accelerated infusion regimen that allows ofatumumab to be delivered in a safe manner while minimizing the time required administering the treatment. We hypothesize there will be fewer infusion-related reactions using the proposed dose-dense approach the first week before accelerating the rate of infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
The first dose of ofatumumab administered on Day 1 will be 300 mg to minimize infusion reactions. If the initial 300 mg dose of ofatumumab is well-tolerated, without occurrence of any infusion-associated AEs of \>= grade 3, on Day 3 ofatumumab will increase to 1000 mg IV. If the Day 3 dose was well-tolerated (i.e., no infusion-associated AE \>= grade 3), on Day 8 the ofatumumab dose will escalate to 2000 mg IV. To achieve the primary endpoint for this study, 20% of the 2000 mg ofatumumab dose only will be administered over the first 30 minutes and if tolerated the remaining 80% of the dose will be infused over the remaining 1.5/hours of each treatment. Ofatumumab doses, weeks 3-8, will remain at 2000 mg IV with no further dose escalations. If the Day 8 (Week 2) dose is tolerated all subsequent doses may be infused in the same manner.
Colorado Blood Cancer Institute
Denver, Colorado, United States
Florida Cancer Specialists-South
Fort Myers, Florida, United States
Florida Cancer Specialists-North
St. Petersburg, Florida, United States
Oncology Hematology Associates
Cincinnati, Ohio, United States
Percent of Patients Who Complete an Accelerated Infusion Regimen Within 15 Minutes of the Planned 2-hour Treatment.
Defined as percent of patients who are able to complete the Day 8 (2000 mg IV Ofatumumab) infusion within 15 minutes of the planned 2-hour treatment goal.
Time frame: At Week 2, Day 1 of therapy
Duration of Time to Complete Individual Infusions of an Accelerated Infusion Schedule of Ofatumumab
Defined as the actual mean infusion times, in minutes, for patients to complete a schedule of 3 infusions with the goal of completing Infusion #3 within 15 minutes of the planned 2-hour treatment time.
Time frame: Week 1 - Days 1 and 3, and Week 2, Day 1
Overall Response Rate (ORR)
Defined as the percent of patients having a complete or partial response (CR or PR) assessed by International Workshop on CLL Working Group (IWCLLWG) Diagnostic Criteria (Hallek et al., 2008). CR = (a) Peripheral blood lymphocytes below 4000/µl; (b) Absence of significant lymphadenopathy by physical exam or radiographic scans (c) No hepatomegaly or splenomegaly; (d) Absence of constitutional symptoms; and blood counts above specified values. PR = (a) Decreased blood lymphocytes by 50% or more from the value prior to therapy;(b) No increase in any lymph node, and no new enlarged lymph node. Progressive Disease (PD) = An increase in 50% or more in greatest determined diameter of any previous site. Stable Disease (SD) = No evidence of CR or PR and no evidence of progressive disease.
Time frame: At weeks 12 and 28
Progression Free Survival
Defined as the time from first treatment until objective tumor progression or death from any cause.
Time frame: For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter.
Overall Survival
Defined as the time from first treatment until death from any cause.
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Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Time frame: For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter.
Number of Patients With Infusion-related Reactions Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0.
Patients who received at least 1 dose of protocol treatment either Infusion #1 (300 mg), Infusion #2 (1000 mg) or Infusion #3 (2000 mg) are included in the assessment.
Time frame: up to 28 weeks