Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALLPhi)

This study has been terminated.
(The study was terminated due to excessive toxicity of the chemotherapy and low compliance to the protocol scheme.)
Sponsor:
Information provided by (Responsible Party):
Rony Schaffel, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00905398
First received: May 15, 2009
Last updated: January 2, 2013
Last verified: January 2013

May 15, 2009
January 2, 2013
May 2009
June 2012   (final data collection date for primary outcome measure)
Complete remission [ Time Frame: Day + 21 and Day + 41 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00905398 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Three years ] [ Designated as safety issue: Yes ]
  • Molecular remission [ Time Frame: Every three months until three years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
  • Acute Lymphoblastic Leukemia
Drug: Nilotinib
400mg, Oral, Bid, Daily for three years
Other Names:
  • Tasigna
  • AMN107
Experimental: nilotinib
single arm study
Intervention: Drug: Nilotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
February 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00905398
BrALL 01-08, ANVISA, 25351732040200851
Yes
Rony Schaffel, Universidade Federal do Rio de Janeiro
Rony Schaffel
Not Provided
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)
Universidade Federal do Rio de Janeiro
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP