Study of Bafetinib as Treatment for Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
A Study of Bafetinib as Treatment for Patients with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)|
- To evaluate the response rate (complete and partial), in subjects with relapsed or refractory B-Cell CLL [ Time Frame: Upto 6 months or disease progression ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
250 mg orally twice daily. Treatment continues until clinically significant disease progression or unacceptable toxicity is documented.
Other Name: INNO-406
Bafetinib is a dual protein kinase inhibitor, targeting both bcr/abl and Lyn kinases. B-cell chronic lymphocytic leukemia cells overexpress Lyn kinase compared to normal B lymphocytes as well as acute leukemias (ALL and AML), and inhibition of Lyn kinase induces apoptosis in cultures of B-CLL cells. Thus, bafetinib may stop the growth of B-CLL cells by inhibiting Lyn kinase, the molecule that couples the B cell receptor to downstream signaling.
|United States, California|
|City of Hope National Medical Center|
|Duarte, California, United States, 91010|
|United States, Texas|
|UT M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Director:||Daniel Levitt, M.D., Ph.D.||CytRx|