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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
Sponsor:
Information provided by (Responsible Party):
Rony Schaffel, Universidade Federal do Rio de Janeiro

Brief Summary:

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2009
Actual Primary Completion Date : June 2012
Estimated Study Completion Date : July 2015


Arm Intervention/treatment
Experimental: nilotinib
single arm study
Drug: Nilotinib
400mg, Oral, Bid, Daily for three years
Other Names:
  • Tasigna
  • AMN107




Primary Outcome Measures :
  1. Complete remission [ Time Frame: Day + 21 and Day + 41 ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Three years ]
  2. Molecular remission [ Time Frame: Every three months until three years ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Rony Schaffel
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)

Responsible Party: Rony Schaffel, MD, PhD, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00905398     History of Changes
Other Study ID Numbers: BrALL 01-08
ANVISA
25351732040200851
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2015

Keywords provided by Rony Schaffel, Universidade Federal do Rio de Janeiro:
Leukemia
Lymphoblastic
Acute
Philadelphia
BCR-ABL
Nilotinib
Treatment

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Philadelphia Chromosome
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes