Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALLPhi)
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|ClinicalTrials.gov Identifier: NCT00905398|
Recruitment Status : Terminated (The study was terminated due to excessive toxicity and low compliance to the protocol scheme.)
First Posted : May 20, 2009
Last Update Posted : July 9, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma Acute Lymphoblastic Leukemia||Drug: Nilotinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada|
|Study Start Date :||May 2009|
|Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||July 2015|
single arm study
400mg, Oral, Bid, Daily for three years
- Complete remission [ Time Frame: Day + 21 and Day + 41 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905398
|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)|