Clinical Trial: Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response

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

Official Title: A Phase IV Study of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have Suboptimal Molecular

Brief Summary: To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: MMR Rate at 12 Mos. of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Molecular Response to Imatinib at 18 Months or Later. [ Time Frame: 12 months after treatment ]

MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value


Original Primary Outcome: To evaluate the MMR rate at 12 months of nilotinib treatment on study in patients with Ph+ CML in CP who have a suboptimal molecular response to imatinib at 18 months or later. [ Time Frame: 12 months after treatment ]

Current Secondary Outcome:

  • MMR Rate at 24 Months of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) [ Time Frame: 24 months after treatment ]
    MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value
  • Time to First MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) . [ Time Frame: month 24 ]
    MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value
  • Duration of MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) . [ Time Frame: month 24 ]
    MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value


Original Secondary Outcome:

  • To evaluate the MMR rate at 24 months of nilotinib treatment on study in patients with Ph+ CML in CP [ Time Frame: 24 months after treatment ]
  • To evaluate the time to and duration of MMR of nilotinib in patients with Ph+ CML in CP. [ Time Frame: month 12 and month 24 ]
  • To evaluate the safety profile of nilotinib in patients with Ph+ CML in CP. [ Time Frame: month 12 and month 24 ]


Information By: Novartis

Dates:
Date Received: January 5, 2010
Date Started: December 2009
Date Completion:
Last Updated: March 10, 2016
Last Verified: March 2016