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

Primary Purpose

Leukemia, Myeloid, Chronic, BCR-ABL Positive

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Imatinib and Nilotinib
Sponsored by
Hospital Universitario Dr. Jose E. Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Chronic, BCR-ABL Positive focused on measuring Chronic myeloid leukemia, suboptimal response, imatinib, nilotinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imatinib and nilotinib combination

Arm Description

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.

Outcomes

Primary Outcome Measures

Major molecular response
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

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

Full Information

First Posted
October 26, 2012
Last Updated
January 3, 2014
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01819389
Brief Title
Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance
Official Title
Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Collaborators
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Chronic, BCR-ABL Positive
Keywords
Chronic myeloid leukemia, suboptimal response, imatinib, nilotinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imatinib and nilotinib combination
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Imatinib and Nilotinib
Other Intervention Name(s)
Gleevec, Tasigna
Primary Outcome Measure Information:
Title
Major molecular response
Description
Major molecular response will be evaluated with quantitative Real time polymerase chain reaction assay (RT-PCR)for BCR/ABL at 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Drugs adverese effects
Description
Patients will be evaluated every four weeks to identify possible adverse effects of drugs administered.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Adherence
Description
Every month adherence will be assessed with a questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Servicio de Hematologia, Hospital Universitario "José E. Gonzalez"
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
20507881
Citation
Schoffski P, Reichardt P, Blay JY, Dumez H, Morgan JA, Ray-Coquard I, Hollaender N, Jappe A, Demetri GD. A phase I-II study of everolimus (RAD001) in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors. Ann Oncol. 2010 Oct;21(10):1990-1998. doi: 10.1093/annonc/mdq076. Epub 2010 May 27.
Results Reference
background
PubMed Identifier
22986736
Citation
Gomez-Almaguer D, Tarin-Arzaga L, Cantu-Rodriguez O, Ceballos-Lopez A. More about imatinib and nilotinib combination therapy in chronic myeloid leukemia. Acta Haematol. 2013;129(1):18-9. doi: 10.1159/000342455. Epub 2012 Sep 12. No abstract available.
Results Reference
background
PubMed Identifier
22286512
Citation
Zhu GR, Ji O, Ji JM, Zhang YC, Wu Y, Yu H, Jiang PJ, Shen Q. Combining nilotinib and imatinib improves the outcome of imatinib-resistant blast phase CML. Acta Haematol. 2012;127(3):152-5. doi: 10.1159/000333107. Epub 2012 Jan 27.
Results Reference
background
PubMed Identifier
26871197
Citation
Gomez-Almaguer D, Saldana-Vazquez R, Tarin-Arzaga L, Herrera-Rojas MA, Vazquez-Mellado de Larracoechea A, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Jaime-Perez JC. Combination of low-dose imatinib plus nilotinib for the treatment of chronic-phase chronic myeloid leukaemia after imatinib failure. Hematology. 2016 Aug;21(7):411-4. doi: 10.1080/10245332.2015.1119369. Epub 2016 Feb 16.
Results Reference
derived

Learn more about this trial

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

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