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OpenTrials
Completed

NCT Number: NCT01819389

Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance

The purpose of this study is to determine if low-dose imatinib and nilotinib combination, will improve treatment results in CML patients with failure, suboptimal response or intolerance to imatinib therapy.

The hypothesis is that with low-dose imatinib and nilotinib combination, major molecular response will be achieved in patients not previously obtained with imatinib monotherapy.

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Key information

Conditions

Leukemia, Myeloid, Chronic, BCR-ABL Positive Bone Marrow Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Disease Attributes Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Lung Diseases Lung Diseases, Obstructive Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Servicio de Hematologia, Hospital Universitario "José E. Gonzalez"

Monterrey, Nuevo León, 64460, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CML patients with failure or suboptimal response to imatinib therapy according to criteria established by the European Leukemia Net (ELN)
  • Patients with grade II or higher adverse events.
  • CML patients not suitable for stem cell transplantation.

Exclusion criteria

  • Patients in blast crisis.
  • Pregnant women
  • Patients without a contraception method.

Treatment and study plan

Imatinib and Nilotinib

Drug

Other names: Gleevec, Tasigna

Primary outcomes

  1. Major molecular response

    Time frame: 6 months

    Major molecular response will be evaluated with quantitative Real time polymerase chain reaction assay (RT-PCR)for BCR/ABL at 6 months.

Secondary outcomes

  1. Drugs adverese effects

    Time frame: 6 months

    Patients will be evaluated every four weeks to identify possible adverse effects of drugs administered.

Other outcomes

  1. Adherence

    Time frame: 6 months

    Every month adherence will be assessed with a questionnaire

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 27, 2013
Registry last updated
Jan 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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