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

July 7, 2015 updated by: Rony Schaffel

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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Nilotinib
400mg, Oral, Bid, Daily for three years
Other Names:
  • Tasigna
  • AMN107

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

This is where you will find people and organizations involved with this study.

Sponsor

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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

May 15, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

July 9, 2015

Last Update Submitted That Met QC Criteria

July 7, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

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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