Spots Global Cancer Trial Database for Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase
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Trial Identification
Brief Title: Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase
Official Title: A Phase II, Multicentre Study of Oral LBH589 in Patients With Accelerated Phase or Blast Phase (Blast Crisis) Chronic Myeloid Leukemia With Resistant Disease Following Treatment With at Least Two BCR-ABL Tyrosine Kinase Inhibitors
Study ID: NCT00449761
Conditions
Interventions
Study Description
Brief Summary: This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
Detailed Description: study was designed to assess the hematologic response associated with treatment of oral panobinostat. Hematologic response is defined as the overall of complete hematologic response (CHR), and of no evidence of leukemia (NEL) and of the return to chronic phase (RTC). Hematologic responses were to be confirmed after 4 weeks, and all criteria listed below for each type of response were to be concomitantly met to result into a response.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
University of Colorado Health Sciences Center/Anschutz Cancer Pavilion, Aurora, Colorado, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
Northwestern University Clinical Research Office, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University Chicago Hospital, Chicago, Illinois, United States
Indiana Blood and Marrow Institute/St. Francis Hospital, Beech Grove, Indiana, United States
University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Hackensack University Medical Center/Oncology Research Dept., Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Duke University Hospital, Durham, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Oregon Health & Science University, Portland, Oregon, United States
Emory University School of Medicine-Winship Cancer Institute, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Clinical Trials Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Novartis Investigative Site, Cologne, , Germany
Novartis Investigative Site, Duesseldorf, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Mainz, , Germany
Novartis Investigative Site, Mannheim, , Germany
Novartis Investigative Site, Munich, , Germany
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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