- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00905398
Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALLPhi)
Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: nilotinib
single arm study
|
400mg, Oral, Bid, Daily for three years
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete remission
Time Frame: Day + 21 and Day + 41
|
Day + 21 and Day + 41
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: Three years
|
Three years
|
Molecular remission
Time Frame: Every three months until three years
|
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
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- 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)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BrALL 01-08
- ANVISA
- 25351732040200851
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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