InCroMiel I

Phase 4

Conditions: Chronic Myeloid Leukemia.
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia
Myeloproliferative Disorders
Bone Marrow Diseases
Hemic Diseases

Registration Number: RPCEC00000050

Lead Sponsor: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Informed consent given by the patient. 2.Diagnosis of Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase/or a positive RT-PCR analysis for the BCR-ABL gene fusion. 3.Pacients from both sexes, must be eighteen years of age or older. 4.Patients who haven’t previously been treated with interferon alfa. 5.Obtain a clinical-haematological remission during the treatment with chemotherapy.

Exclusion Criteria

1.Pregnant or lactating women. 2.Fertile age women that are under hormone anti-conceptive therapy or that they haven’t control of their fertility. 3.A history of hypersensitivity to interferon or any excipient in the study treatment 4.Patients with accelerated phase or blastic crisis. 5.Extramedular blastic crisis. 6.Acute or chronic hepatic disease (AST and ALT > 2 times upper limit of normal and/or serum total bilirubin >17 micromol/L). 7.Renal failure. 8.Cardiac failure and/or decompensated arterial hypertension. 9.Mental impairment that may compromise the ability to give informed consent and comply with the study requirements.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interval free of blastic crisis. Measurement time: 2 years. Survival. Measurement time: 2 years.

Secondary Outcome Measures

Name	Time	Method
1.Interval free of relapse. Measurement time: 2 years. 2.Number of relapses.Measurement time: 2 years. 3.Clinic-haematological response. Measurement time: 2 years. 4.Cytogenetics response. Measurement time: 2 years. 5.Proportion of patients that develops adverse events.Measurement time: 2 years. 6.Proportion of patients that develops antibodies anti-IFN. Measurement time: 2 years.