Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE October 26, 2012
First Posted Date  ICMJE March 27, 2013
Last Update Posted Date January 7, 2014
Study Start Date  ICMJE October 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01819389 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2013)
Drugs adverese effects [ Time Frame: 6 months ]
Patients will be evaluated every four weeks to identify possible adverse effects of drugs administered.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 24, 2013)
Adherence [ Time Frame: 6 months ]
Every month adherence will be assessed with a questionnaire
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance
Official Title  ICMJE Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Myeloid, Chronic, BCR-ABL Positive
Intervention  ICMJE Drug: Imatinib and Nilotinib
Other Names:
  • Gleevec
  • Tasigna
Study Arms  ICMJE 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.
Intervention: Drug: Imatinib and Nilotinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2014)
10
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2013)
12
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01819389
Other Study ID Numbers  ICMJE HE12-019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
Study Sponsor  ICMJE Hospital Universitario Dr. Jose E. Gonzalez
Collaborators  ICMJE Novartis Pharmaceuticals
Investigators  ICMJE Not Provided
PRS Account Hospital Universitario Dr. Jose E. Gonzalez
Verification Date January 2014

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