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
  Purpose

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 Intervention Phase
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Acute Lymphoblastic Leukemia
Drug: Nilotinib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Complete remission [ Time Frame: Day + 21 and Day + 41 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: May 2009
Estimated Study Completion Date: February 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nilotinib
single arm study
Drug: Nilotinib
400mg, Oral, Bid, Daily for three years
Other Names:
  • Tasigna
  • AMN107

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

No publications provided

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
Study First Received: May 15, 2009
Last Updated: January 2, 2013
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health

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

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
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

ClinicalTrials.gov processed this record on September 18, 2014