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

Phase 3CompletedNCT01819389

Hospital Universitario Dr. Jose E. Gonzalez10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia, Myeloid, Chronic, BCR-ABL Positive

Interventions

Imatinib and NilotinibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Monterrey, Nuevo León, Mexico

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Drugs adverese effects

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

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.