InCroMiel I

Phase 4

Completed

• 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

Study Timeline

• Study Start: 2009-12-24
• Last Update Posted: 2024-08-19

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