Trial | NCT00905398  Report issue

Title

Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    nilotinib ...

  • Study Participants

    8
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.
Study Started
May 31
2009
Primary Completion
Jun 30
2012
Study Completion
Jul 31
2015
Anticipated
Last Update
Jul 09
2015
Estimate

Drug Nilotinib

400mg, Oral, Bid, Daily for three years

  • Other names: Tasigna, AMN107

nilotinib Experimental

single arm study

Criteria 

Inclusion Criteria:

Diagnosis of Acute Lymphoblastic Leukemia (ALL)
BCR-ABL positive positive by PCR (central Lab)
No previous treatment for ALL except for corticoids and cyclophosphamide less than 600 mg/m2
Must be able to swallow tablets
Lab results within normal limits (Potassium, Calcium, Magnesio, Phosphorus, Transaminases, Alkaline Phosphatase, Bilirrubine, Amylase, Lypase)

Exclusion Criteria:

Heart disease
Interval QTc Fridericia > 480 msec
Coumadin use
Pregnancy
PS = 4
Previous medical history of etilism or/and pancreatic disease
No Results Posted