Chronic Myeloid Leukemia.
Conditions
Interventions
Induction: Busulfan (BU), Cyclophosphamide (CFM) and/or Hydroxyurea (HU) considering the patient in remission when lecucocitos keep count 5 to 10x109 / L for more than 4 weeks. Maintenance: IFN-alfa 2
Interferon-alpha
Busulfan
Cyclophosphamide
Hydroxyurea
Injections, Intramuscular
Sponsors
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interval free of blastic crisis. Measurement time: 2 years. Survival. Measurement time: 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Cuba
Contacts
Public ContactYanelda Garcia Vega
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
Outcome results
None listed