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

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Completed; Phase 3

Conditions: Leukemia, Myeloid, Chronic, BCR-ABL Positive

Treatments: Drug: Imatinib and Nilotinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01819389

HE12-019

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Imatinib and nilotinib combination

Experimental group

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.

Treatment:

Drug: Imatinib and Nilotinib