Study on Belinostat and Zidovudine for Treating Adult T-Cell Leukemia-Lymphoma

Inclusion Criteria

• Diagnosed with adult T-cell leukemia/lymphoma (ATLL) at any stage, with aggressive types and ATLL cells present in the blood.
• Previously treated with AZT/IFNα therapy or chemotherapy, showing at least a partial response without new disease growth.
• Residual ATLL cells in the blood during screening.
• Confirmed infection with Human T-cell lymphotropic virus type 1 (HTLV-1).
• Measurable or detectable disease, including molecular evidence of T-cell clonality.
• Aged 18 years or older.
• Performance status score of at least 50% (Karnofsky) or 3 or less (ECOG).
• Adequate organ and bone marrow function, with specific blood count and liver function levels.
• HIV-positive patients are eligible.
• Women of childbearing potential must have a negative pregnancy test and agree to use birth control during and after the study.
• Patients receiving erythropoietin or G-CSF are eligible.

Exclusion Criteria

• Disease progression after previous chemotherapy or AZT/IFNα treatment.
• Chronic leukemia with favorable features or smoldering type ATLL.
• Use of other investigational drugs within 14 days before starting the study, except certain forms of IFN-alfa.
• Uncontrolled illnesses like active infections, heart failure, unstable heart conditions, or psychiatric issues.
• Pregnant or breastfeeding women.
• Allergies to study drugs or their components.
• Acute hepatitis or severe liver disease unless due to lymphoma.
• Other active cancers, except certain non-threatening types.
• Severe heart disease or low heart function.
• Conditions that may interfere with study participation.