Clinical trial NCT01819389: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leukemia, Myeloid, Chronic, BCR-ABL Positive
Keywords: Chronic myeloid leukemia
suboptimal response
imatinib
nilotinib
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2013-03-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Major molecular response
timeFrame: 6 months
Secondary outcomes:
measure: Drugs adverese effects
timeFrame: 6 months
Other outcomes:
measure: Adherence
timeFrame: 6 months
Locations:
city: Monterrey
country: Mexico
facility: Servicio de Hematologia, Hospital Universitario "José E. Gonzalez"
state: Nuevo Leon
Study officials:
References:
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.
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.
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.
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.