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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
30 mg, 45 mg
1.0mg/m2, 1.3 mg/m2
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
Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile
Time frame: 4 weeks to 2 years
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements
Time frame: 4 weeks to 2 years
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University of Wisconsin
Madison, Wisconsin, United States