Clinical Trial: Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia (CML) in Accelerated Phase or Blast Phase (Blast Crisis)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II, Multicentre Study of Oral LBH589 in Patients With Accelerated Phase or Blast Phase (Blast Crisis) Chronic Myeloid Leukemia With Re

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 Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Hematologic response (complete hematologic response (CHR) / no evidence of leukemia (NEL) / return to chronic phase (RTC)) rate assessed by a blood test [ Time Frame: throughout the study ]

Original Primary Outcome: Hematologic response (complete hematologic response (CHR) / no evidence of leukemia (NEL) / return to chronic phase (RTC)) rate assessed by a blood test

Current Secondary Outcome:

  • Duration of the hematologic response and cytogenetic response [ Time Frame: throughout the study ]
  • Complete cytogenetic response (CCyR) rate assessed by bone marrow assessment [ Time Frame: throughout the study ]
  • Major (complete/partial) cytogenetic response rate assessed by bone marrow assessment [ Time Frame: throughout the study ]
  • Overall (complete/partial/minor/minimal) cytogenetic response rate assessed by bone marrow assessment [ Time Frame: throughout the study ]


Original Secondary Outcome:

  • Duration of the hematologic response and cytogenetic response
  • Complete cytogenetic response (CCyR) rate assessed by bone marrow assessment
  • Major (complete/partial) cytogenetic response rate assessed by bone marrow assessment
  • Overall (complete/partial/minor/minimal) cytogenetic response rate assessed by bone marrow assessment


Information By: Novartis

Dates:
Date Received: March 20, 2007
Date Started: February 2007
Date Completion:
Last Updated: November 16, 2016
Last Verified: November 2016