Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALLPhi)
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.
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Acute Lymphoblastic Leukemia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada|
- Complete remission [ Time Frame: Day + 21 and Day + 41 ] [ Designated as safety issue: Yes ]
- Overall Survival [ Time Frame: Three years ] [ Designated as safety issue: Yes ]
- Molecular remission [ Time Frame: Every three months until three years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||February 2013|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
single arm study
400mg, Oral, Bid, Daily for three years
|Principal Investigator:||Rony Schaffel, MD, PHD||Rio de Janeiro Federal University|
|Study Chair:||Nelson Spector, MD, PHD||Rio de Janeiro Federal University|
|Principal Investigator:||Belinda Simões, MD, PHD||São Paulo University (Ribeirão Preto)|