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Brief Title: Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Official Title: A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Study ID: NCT00407303
Brief Summary: Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.
Detailed Description: This is a multi-center, open-label, Phase I study of Obatoclax administered in combination with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell Lymphoma. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patients's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
NW Georgia Oncology Centers, Marietta, Georgia, United States
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Medical Center, Buffalo, New York, United States
University of Wisconsin, Madison, Wisconsin, United States
Name: Jean Viallet, MD
Affiliation: Gemin X, Inc.
Role: STUDY_DIRECTOR