Clinical Trial: Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada
Brief Summary:
Patients with acute lymphoblastic leukemia and positivity for the breakpoint cluster region-Abelson murine leukemia (BCR-ABL) protein or the Philadelphia chromosome have a poor prognosis with standard chemotherapy. The prognosis seemed to improve following the adition of imatinibe, a BCR-ABL inhibitor, to the treatment but still a substantial amount of patients relapse or progress during treatment.
Nilotinib is a BCR-ABL inhibitor more potent than imatinib. It has been shown to be effective against most of the cells that bear mutations of the BCR-ABL protein leading to resistance to imatinibe.
The investigators' hypothesis is that the addition of nilotinib to a standard chemotherapy for acute lymphoblastic leukemia (ALL) will translate into more rapid BCR-ABL reduction and effectiveness against imatinib-resistant clones leading to less relapses and better survival.
Detailed Summary:
Sponsor: Rony Schaffel
Current Primary Outcome: Complete remission [ Time Frame: Day + 21 and Day + 41 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall Survival [ Time Frame: Three years ]
- Molecular remission [ Time Frame: Every three months until three years ]
- Toxicity [ Time Frame: Three times a week for the first 40 days than once weekly for the next 9 months than monthly for the next 2.1 years ]
Original Secondary Outcome: Same as current
Information By: Universidade Federal do Rio de Janeiro
Dates:
Date Received: May 15, 2009
Date Started: May 2009
Date Completion: July 2015
Last Updated: July 7, 2015
Last Verified: July 2015
