Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT01848145|
Recruitment Status : Completed
First Posted : May 7, 2013
Results First Posted : June 6, 2017
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Ofatumumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia, a Phase II Trial|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||March 2017|
Rapid Infusion of Ofatumumab
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.
Other Name: Arzerra
- Percent of Patients Who Complete an Accelerated Infusion Regimen Within 15 Minutes of the Planned 2-hour Treatment. [ Time Frame: At Week 2, Day 1 of therapy ]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.
- Duration of Time to Complete Individual Infusions of an Accelerated Infusion Schedule of Ofatumumab [ Time Frame: Week 1 - Days 1 and 3, and Week 2, Day 1 ]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.
- Overall Response Rate (ORR) [ Time Frame: At weeks 12 and 28 ]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.
- Progression Free Survival [ Time Frame: For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter. ]Defined as the time from first treatment until objective tumor progression or death from any cause.
- Overall Survival [ Time Frame: For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter. ]Defined as the time from first treatment until death from any cause.
- Number of Patients With Infusion-related Reactions Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0. [ Time Frame: up to 28 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848145
|United States, Colorado|
|Colorado Blood Cancer Institute|
|Denver, Colorado, United States, 80218|
|United States, Florida|
|Florida Cancer Specialists-South|
|Fort Myers, Florida, United States, 33916|
|Florida Cancer Specialists-North|
|Saint Petersburg, Florida, United States, 33705|
|United States, Ohio|
|Oncology Hematology Associates|
|Cincinnati, Ohio, United States, 45242|
|United States, Tennessee|
|Chattanooga Oncology Hematology Associates|
|Chattanooga, Tennessee, United States, 37404|
|Tennessee Oncology PLLC|
|Nashville, Tennessee, United States, 37203|
|Study Chair:||Ian Flinn, MD, PhD||SCRI Development Innovations, LLC|