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

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ClinicalTrials.gov Identifier: NCT01819389
Recruitment Status : Completed
First Posted : March 27, 2013
Last Update Posted : January 7, 2014
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Chronic, BCR-ABL Positive Drug: Imatinib and Nilotinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.
Study Start Date : October 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013


Arm Intervention/treatment
Experimental: Imatinib and nilotinib combination
All patients will receive treatment as follows: imatinib 100 mg tablets, 200 mg daily for 6 months; and nilotinib 150 mg capsule, 300 mg daily for 6 months.
Drug: Imatinib and Nilotinib
Other Names:
  • Gleevec
  • Tasigna




Primary Outcome Measures :
  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 Outcome Measures :
  1. Drugs adverese effects [ Time Frame: 6 months ]
    Patients will be evaluated every four weeks to identify possible adverse effects of drugs administered.


Other Outcome Measures:
  1. Adherence [ Time Frame: 6 months ]
    Every month adherence will be assessed with a questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT01819389


Locations
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Mexico
Servicio de Hematologia, Hospital Universitario "José E. Gonzalez"
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Novartis Pharmaceuticals

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Gomez Almaguer, MD, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01819389     History of Changes
Other Study ID Numbers: HE12-019
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez:
Chronic myeloid leukemia
suboptimal response
imatinib
nilotinib

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action