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.

Dr. John Leonard Addresses When to Treat Patients with Follicular Lymphoma

In this video from OncLive, Lymphoma Program Director, Dr. John Leonard addresses the question of when is the best time to treat patients with follicular lymphoma. Noting that the majority of follicular lymphoma patients will not die from their disease, he suggests treatment should be based on symptomatic progression.

 

New Clinical Trial: A Phase 1 Study to Investigate the Safety & Tolerability of REGN1979 in Patients with CD20+ B-Cell Malignancies Previously Treated with CD20-Directed Antibody Therapy

The Weill Cornell Lymphoma Program has recently opened a new research study for men and women with CD20+ B-cell malignancies, including B-NHL’s and CLL. The study is sponsored by Regeneron Pharmaceuticals, Inc. and the principal investigator is John Allan, MD. For more information about the study, please call Amelyn Rodriguez at 212-746-1362 or email her at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older.
  • Diagnosis of CD20+ B-cell malignancy (B-NHL or CLL), with active disease not responsive to prior therapy.
  • Prior treatment with an anti-CD20 antibody therapy.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

This clinical trial is for men and women with CD20+ B-cell malignancies, including B-NHL and CLL.

The anti-CD20 monoclonal antibody (mAb), rituximab, has dramatically improved the prognosis for patients with NHL, and has been a mainstay of treatment since its first approval in 1997. While rituximab has single-agent activity in both indolent and aggressive NHL, and more modest activity in CLL, the standard of care is to use it in combination with chemotherapy. Response rates to conventional therapy are generally greater than 50%, but most patients will relapse. In the relapsed or salvage setting, there are no standard of care options and the choice of therapy is often guided by patient clinical factors, including performance status and the presence of comorbidities. Additionally, there is a growing body of data demonstrating the development of diminished activity of rituximab and rituximab resistance over time in multiple NHL subtypes.

REGN1979 is a bispecific (anti-CD20 and anti-CD3) monoclonal antibody, designed with a novel mechanism of action that is distinct from that of other anti-CD20 antibodies, and as such may provide a therapeutic benefit in patients who have relapsed following anti-CD20 mAb therapy. This first in human phase 1 study is designed to investigate the safety and tolerability of REGN1979.

Subjects will be assigned to a dose level cohort that will consist of an initial starting dose, followed by a higher dose for all subsequent administrations. REGN1979 will be administered as an IV infusion, weekly for the first four weeks, then monthly for five months, for a total of nine doses over six months. After completing the treatment period, subjects will have follow-up visits monthly for six months.

New First Line Therapy Approved for CLL

The Backstory

Earlier this month, the FDA approved ibrutinib for first-line use in patients with chronic lymphocytic leukemia (CLL). This makes it the first FDA-approved non-chemotherapy option for initial CLL treatment. The approval adds an alternative to current first line standard treatments which include fludarabine, cyclophosphamide, and rituximab as well as chlorambucil and obinutuzumab.

This is the fifth approval granted to ibrutinib by the FDA and third approval related to CLL. The previous FDA-approved indications included previously treated CLL (February 2014) and patients with 17p deletion (July 2014). Other prior approvals included ibrutinib for use as a monotherapy in patients with Waldenstrom’s macroglobulinemia (July 2015) and as a treatment for mantle cell lymphoma patients who received at least one prior therapy (November 2013).

What is ibrutinib?

Ibrutinib is a first-generation oral drug that inhibits Bruton’s tyrosine kinase (BTK), an enzyme that plays a role in the development of B-cells. In CLL, malignant B-cells grow uncontrollably and prevent other blood cells from properly forming. Ibrutinib disrupts the function of BTK, slowing cell growth and promoting cell death in CLL cells.

Why was ibrutinib granted FDA approval?

Ibrutinib was approved based on the results from the RESONATE-2 trial. Ibrutinib was found to have superior results when compared to the standard chemotherapy treatment, chlorambucil, in a large study of older CLL patients who had not previously received any treatment. Overall, there was an 84% decrease in the risk of death when treated with ibrutinib compared to chlorambucil. These results were presented at the latest American Society of Hematology meeting and published in the New England Journal of Medicine. (December 2015)

Were there any side effects?

Side effects related to ibrutinib included diarrhea, fatigue, coughing, and nausea. Few patients required treatment discontinuation or dose reductions due to adverse side effects of the medication.

How can you access ibrutinib? 

Ibrutinib has been approved for use in CLL, mantle cell lymphoma, and Waldenstrom’s macroglobulinemia, and researchers are attempting to optimize its use in those lymphomas while continuing to investigate its use in other forms of lymphoma. To learn more about whether this is the best treatment for you please call us at (646) 962-2064 and make an appointment with one of our physicians. A full list ibrutinib-related trials currently open at Weill Cornell Medicine can be found on our Joint Clinical Trials website, including two trials for patients with CLL.