Clinical Trial: Efficacy and Safety Study of Dasatinib in Patients With Chronic Myeloid Leukemia
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase II Efficacy and Safety Study of Dasatinib in Patients With Chronic and Accelerated Phase Chronic Myeloid Leukemia Relapsing After Allogeneic Blood or Bone Marrow Tra
Brief Summary:
This is a phase II efficacy (indicates the capacity for beneficial change or therapeutic effect) and safety study of Dasatinib in patients with relapsed Chronic Myeloid Leukemia (CML) following a Stem Cell Transplant (SCT) and who are not benefiting from other treatment, such as imatinib therapy.
A relapse is when an illness that has seemed to be getting better, or to have been cured, comes back or gets worse again.
A total of 50 patients ≥18 years of age will be registered on the trial.
Detailed Summary:
Primary Objective:
- To assess the efficacy of Dasatinib therapy in chronic and accelerated phase BCR-ABL (+) (Ph + and Ph -) CML patients that undergo molecular, cytogenetic or haematological relapse following SCT.
Secondary Objective(s):
- To assess the impact of Dasatinib therapy on patient survival after relapse post-SCT and the incidence of any subsequent need for 'rescue' DLI.
- To assess the safety of Dasatinib in this clinical context using this specific dose regimen
Chronic myeloid leukaemia (CML) is a form of cancer that starts in cells within the bone marrow called haematopoietic stem cells. Stem cells are immature cells which can divide many times and eventually produce all the lymphocytes and myeloid cells present in the blood. They are produced in the bone marrow - the spongy tissue found in large bones, including the pelvis, sternum, limb bones and the ribs.
Leukaemia is a cancer of the white blood cells. In CML, too many myeloid cells (one of the main types of white blood cells which defend the body against infectious diseases) are produced. The myeloid cells are released into the blood when they are immature and unable to work properly. These immature white blood cells are known as blasts.
The immature cells fill up the bone marrow and prevent it from making blood cells properly. As the leukaemia cells do not mature, they can't do the work of normal white blood cells, which leads to an increased risk of infection. Because the bone marrow is overcrowded with immature white cells it also can't make enough h
Sponsor: European Group for Blood and Marrow Transplantation
Current Primary Outcome: CMR as determined by two consecutive (-) RT-PCR tests for the presence of BCR-ABL transcripts in peripheral blood samples 1 year after starting Dasatinib therapy. The expected CMR of >30% would be regarded as being clinically relevant [ Time Frame: 4 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Complete haematological response (CHR) at 3 months post commencing Dasatinib for those that have relapsed at the haematological level. [ Time Frame: 4 years ]
- Complete cytogenetic response (CCyR) at 6 and 12 months post commencing Dasatinib for those that have relapsed at the cytogenetic level. [ Time Frame: 4 years ]
- Major molecular response (MMR) at 12 months post commencing Dasatinib for all patients. [ Time Frame: 4 years ]
- Proportion of patients requiring DLI during the first 12 months [ Time Frame: 4 years ]
- Overall survival (OS) - Limited to 3 years. [ Time Frame: 4 years ]
- Progression free survival (PFS). [ Time Frame: 4 years ]
- Adverse event (AE) rate. [ Time Frame: 4 years ]
- Rate of dose reductions, interruptions and discontinuations. [ Time Frame: 4 years ]
Original Secondary Outcome: Same as current
Information By: European Group for Blood and Marrow Transplantation
Dates:
Date Received: May 6, 2009
Date Started: February 2010
Date Completion:
Last Updated: December 6, 2011
Last Verified: December 2011
