A Phase II Study of Thrice Weekly Apolizumab in Patients With Chronic Lymphocytic Leukemia : CRC Master Protocol
I. Determine the response rate and progression-free survival rate in patients with relapsed
or refractory chronic lymphocytic leukemia (CLL) or noncontiguous stage II or stage III or
IV small lymphocytic lymphoma treated with apolizumab.
II. Determine the safety of this drug, in terms of the frequency and severity of
treatment-related adverse events, in these patients.
I. Determine clinical response to apolizumab varies by genetic subtype of CLL. II. Determine
if pharmacokinetic clearance is truly predicted by 1D10 antigen density on the individual
patient CLL cell and how apolizumab clearance correlates with response and selected
III. To determine the importance of reactive oxygen species and specific signaling pathways
in promoting apolizumab-mediated apoptosis in vitro and in vivo in primary CLL cells and if
this correlates with clinical response to therapy.
IV. To determine the cellular properties which convey resistance to apolizumab in CLL in
OUTLINE: This is a multicenter study.
Patients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22,
24, and 26 in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 week, at 1 and 2 months, every 3 months for 1 year, and then
every 6 months for 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (CR+PR)
Up to 3 years
Ohio State University
United States: Food and Drug Administration
|Ohio State University Medical Center||Columbus, Ohio 43210|
|Chronic Lymphocytic Leukemia Research Consortium (CRC)||La Jolla, California 92093-0820|