A Blog from the Lymphoma Program at Weill Cornell Medicine and NewYork-Presbyterian
Author: lymphomaprogram
Located on the Upper East Side of New York City, the Lymphoma Program at Weill Cornell Medical College/NewYork Presbyterian Hospital is internationally recognized for our efforts to enable patients with non-Hodgkin lymphoma, Hodgkin disease and related disorders to have the best possible clinical outcome, including cure when possible.
Be sure to tune in or set your DVR tomorrow morning, extra early at 6am when Lymphoma Program Director, Dr. John Leonard will appear on Fox 5’s Good Day Street Talk with current patient Robert Azopardi to discuss the Lymphoma Program at Weill Cornell/NewYork Presbyterian Hospital and the forthcoming LLS Light the Night event on Thursday, October 6 beginning at 5:30 pm in Rumsey Playfield Central Park.
Last month, the FDA approved the use of ofatumumab in combination with fludarabine and cyclophosphamide to treat patients with relapsed chronic lymphocytic leukemia (CLL).
This is the 4th FDA approval received by ofatumumab for the treatment of patients with CLL. Ofatumumab was initially approved in 2009 for the treatment of patients with CLL who are refractory to fludarabine and alemtuzumab, and subsequently approved in April 2014 for use in combination with chlorambucil for previously untreated patients with CLL. In January 2016 ofatumumab was approved for the treatment of patients with recurrent or progressive chronic lymphocytic leukemia (CLL) who are in complete or partial response following at least two prior treatment therapies.
What is ofatumumab?
Ofatumumab is a human monoclonal antibody designed to target the CD20 molecules found on the surface of CLL cells and B-cell lymphocytes. CD20 molecules are found in over 90% of B-cell lymphomas. Ofatumumab is an immunotherapy that works by attaching itself to the CD20 molecule found on the surface of B-cells and directs the immune system to kill the cancerous B-cells.
Why was ofatumumab granted FDA approval?
The latest approval for ofatumumab was based on improved progression free survival (PFS) results in the phase III COMPLEMENT-2 study. PFS refers to the length of time following the course of treatment, that a patient’s disease does not get worse, or progress. In this study the median PFS of ofatumumab combined with chemotherapy was 28.9 months compared to 18.8 months for only the fludarabine and cyclophosphamide combination.
Were there any side effects?
Side effects were similar to the side effects found in previous trials. They included infusion reactions, neutropenia, thrombocytopenia, anemia, nausea, leukopenia, vomiting, pyrexia, rash, fatigue, and pneumonia.
How can you access ofatumumab now?
While all available WCM trials with ofatumumab for people with CLL have recently closed, our understanding of how best to use ofatumumab continues to increase. You can look to this space for further updates on CLL trials examining the use of ofatumumab.
What is the difference between CLL stage (Rai or Binet) and SLL stage (Ann Arbor)? Why does the same disease have two different staging systems?
Answer
Dr. Richard Furman, M.D.
Dr. Richard Furman writes: The purpose of a staging system is to help clinicians better determine prognosis and plan treatment for a patient’s disease. Although chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are the same disease, they were not recognized as the same disease until 1994. Since then they have been combined into one entity, CLL/SLL.
For historical reasons, CLL was staged based upon the Rai or Binet scheme (see below) and SLL was staged using the Ann Arbor lymphoma staging scheme (see below). Today most CLL specialists use the Rai stage because it is more clinically helpful. Using the Ann Arbor classification to stage SLL is problematic in scenarios where the disease has spread to the bone marrow. A person with SLL in their lymph nodes and bone marrow would immediately be characterized as an Ann Arbor stage IV, but their prognosis and treatment plan would be far better indicated as measured by the Rai stage I. Therefore the Rai stage, even without lymphocytosis, provides better prognostic and therapeutic information for a physician to treat their patient.
Rai Stages
0: lymphocytosis (an increase in number of lymphocytes in the blood).