The starting dose for all patients will be 90 mg/m2 I.V. over 0.5 hour every other day until CR is achieved (up to a maximum of 56 days elapsed time since the initiation of treatment). Depending upon the observed toxicity level and documented response level, study drug will be maintained at 90 mg/m2 throughout the induction period. However, dosage modifications will be implemented. During the Post-induction phase, the dose of Atragen will be maintained at the final dose during induction and will
Sponsors
INSTITUTO DE ENFERMEDADES NEOPLASICAS,
Unknown Phase
A PHASE II MULTICENTRIC STUDY DESIGNED TO EVALUATE ATRAGEN (LIPOSOMAL TRETINOIN ) COMPASSIVE USE IN THE TREATMENT OF PATIENTS WITH ACUTE PROMYELOCYTIC LEUKEMIA (APL)
Active, not recruitingPER-063-00
Updated: 2023-09-04
PHASE II MULTICENTER STUDY OF ATRAGEN (LIPOSOMAL-TRETINOIN) IN PATIENTS WITH NEWLY DIAGNOSED ACUTE PROMYELOCYTXG LEUKEMIA (APL)
Active, not recruitingPER-062-00
Updated: 2023-09-04