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Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada


Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Both
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Acute Lymphoblastic Leukemia

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Trial Information

Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission

Outcome Time Frame:

Day + 21 and Day + 41

Safety Issue:

Yes

Principal Investigator

Rony Schaffel, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rio de Janeiro Federal University

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

BrALL 01-08

NCT ID:

NCT00905398

Start Date:

May 2009

Completion Date:

February 2013

Related Keywords:

  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
  • Acute Lymphoblastic Leukemia
  • Leukemia
  • Lymphoblastic
  • Acute
  • Philadelphia
  • BCR-ABL
  • Nilotinib
  • Treatment
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Philadelphia Chromosome

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