Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
RATIONALE: Monoclonal antibodies, such as ofatumumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This randomized phase II trial is studying ofatumumab to see how well it works in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Ofatumumab (CALGB IND #) in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)|
- Overall response (complete or partial response) [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
- Comparison of two ofatumumab doses efficacy with historical controls [ Designated as safety issue: No ]
- Comparison of two ofatumumab doses toxicity with historical controls [ Designated as safety issue: Yes ]
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive high-dose ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.
Experimental: Arm II
Patients receive a lower dose of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.
- To determine the response rate in patients with previously untreated CD20-positive bulky stage II, or stage III or IV follicular non-Hodgkin lymphoma (NHL) treated with a lower- or high-dose of ofatumumab.
- To determine the progression-free survival (PFS) of patients treated with these regimens.
- To determine the toxicity profile of these regimens in these patients.
- To establish whether the therapeutic effect of single-agent ofatumumab is sufficiently promising to warrant evaluation in subsequent randomized, ofatumumab-based, biologic doublet trials.
- To evaluate the two ofatumumab doses by independent comparison of response, PFS, and toxicity to a historical control in previously untreated patients with follicular NHL.
- To prospectively validate the FLIPI2 prognostic index in low- and intermediate-risk patients and compare to low- and intermediate-risk stratified patients by standard FLIPI scoring to determine a more reliable indicator of response and PFS.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive high-dose ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.
- Arm II: Patients receive a lower dose of ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22 and then once monthly in months 3-9.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients may undergo blood and bone marrow sample collection for correlative studies.
After completion of study therapy, patients are followed up every 4 months for 2 years and then every 6 months for 8 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190449
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|Principal Investigator:||Cara A. Rosenbaum, MD||University of Chicago|