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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01819389
• Date of registration: 26/10/2012
• Prospective Registration: No
• Primary sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Public title: Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance
• Scientific title: Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.
• Date of first enrolment: October 2012
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01819389
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Mexico

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Leukemia, Myeloid, Chronic, BCR-ABL Positive

Intervention(s)

Drug: Imatinib and Nilotinib

Primary Outcome(s)

Major molecular response [Time Frame: 6 months]

Secondary Outcome(s)

Drugs adverese effects [Time Frame: 6 months]

Secondary ID(s)

HE12-019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis Pharmaceuticals