Published on Roswell Park Cancer Institute (http://www.roswellpark.org)


Title (CALGB 10701) A Phase II Study Of Dasatinib (Sprycel®) (IND #73969, NSC #732517) As Primary Therapy Followed by Transplantation For Adults >/= 50 Years With Newly Diagnosed PH+ Acute Lymphoblastic Leukemia by CALGB, ECOG, and SWOG
Contact ND
Principal Investigator Meir Wetzler, MD
Study Number 185210
Phase2
Summary

This study will study patients with acute lymphoblastic leukemia (ALL) with an abnormal chromosome feature known as the Philadelphia Chromosome.”  Patients diagnosed with ALL with the abnormal Philadelphia chromosome are said to have Philadelphia chromosome positive ALL (abbreviated as Ph+ ALL). 

Dasatinib has been approved by the Food and Drug Administration (FDA) for use in patients diagnosed with chronic myeloid leukemia (abbreviated as CML), another type of leukemia that has the abnormal Ph+ chromosome feature, and in patients with Ph+ ALL  whose leukemia either has not responded to or has returned despite previous therapy.  Its use in patients with newly diagnosed Ph+ ALL is experimental.  The experimental portion of this research study involves the use of Dasatinib in combination with standard chemotherapy and transplantation treatments for Ph+ ALL.  Dasatinib blocks the action of the abnormal chromosome feature, and its use inhibits the growth of leukemia cells.

Eligibility
  • Unequivocal histologic diagnosis of ALL
  • Detection of the t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics or BCR-ABL positive status by molecular analysis (Q-PCR or FISH) in a CLIA approved laboratory.
  • No prior therapy except up to one week of corticosteroids and / or hydroxyurea to enable time for the detection of t(9;22)(q34;q11) or BCR/ABL.
  • Age >= 50 years with no upper age limit.
  • Non-pregnant and non-nursing.
For more information about the clinical study go to Clinicaltrial.Gov

Source URL (retrieved on 05/21/2013 - 5:34am): http://www.roswellpark.org/clinical-trials/list/185210-2