New Clinical Trial: Study to Determine the Safety, Pharmacokinetics, & Efficacy of Single Agent CC-122 with Rituximab/Ibrutinib in Patients with Relapsed & Refractory CLL/SLL

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with relapsed or refractory CLL/SLL. The study sponsor is the Celegene Corporation, and the principal investigator at Weill Cornell is Richard Furman M.D.. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 to 79.
  • Diagnosis of CLL/SLL.
  • Must meet the criteria for relapsed and/or refractory disease.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

This clinical trial is for men and women with relapsed/refractory CLL/SLL.

Subjects on this study will receive the study drug, CC-122, in combination with rituximab or ibrutinib, or as a single agent. CC-122 is an analog of thalidomide and has multiple activities in CLL, including immune modulation (activation of cells in the immune system) and anti-proliferative activity. CC-122 has also been shown to have a tolerable safety profile with some preliminary signs of efficacy with early human experience. Rituximab is a monoclonal antibody directed against a molecule present on the surface of normal B lymphocytes and CLL cells. Ibrutinib is a BTK inhibitor that has received accelerated approval in the United States for patients with CLL who have received at least one prior therapy. This study will provide more information about the efficacy and safety of CC-122 both as a single agent and in combination with rituximab or ibrutinib in subjects with CLL/SLL.

All subjects will receive CC-122 continuously throughout the study as long as they are responding to therapy and not experiencing unacceptable side effects. Some subjects will receive ibrutinib which will be taken continuously throughout the study. Both CC-122 and ibrutinib will be administered orally once daily. Other subjects will receive rituximab which will be administered intravenously on cycle 1 day 1 and 8, and on day 1 of cycle 3, 5, 7, 9, and 11. After discontinuing treatment, subjects will be contacted every 90 days for follow-up information until disease progression, withdrawal of consent, or loss to follow-up.

Subjects may receive up to forty dollars per visit for the reimbursement of travel expenses.

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.

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