Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL

Inclusion Criteria

• •Patients must meet all of the following criteria for admission into the study:
• •1. Have a diagnosis of either relapsed and/or refractory APL:
• •* Refractory disease is defined as a confirmed diagnosis of APL and a myeloblast plus promyelocyte count of \> 10% in the bone marrow in patients who have failed to respond to induction therapy in the first or second line setting. Induction therapy must have included ATRA- and ATO-based therapy given either sequentially or in combination.
• •* Relapsed disease is defined as a confirmed diagnosis of APL and a myeloblast plus promyelocyte count of \> 10% in the bone marrow following a documented complete remission or positive RT-PCR assay for PML/RAR-α in two consecutive tests separated by at least one month, after treatment with ATRA- and ATO-based therapy given either sequentially or in combination.
• •2. Confirmation of diagnosis and relapsed/refractory APL must be obtained in blood or bone marrow mononuclear cells by at least one of the following methods:
• •* Conventional cytogenetics showing the translocation t(15:17),
• •* Positive RT-PCR assay for PML/RAR-α, or
• •* Fluorescence in situ hybridization (FISH) analysis showing evidence of the PML/RAR-α translocation.
• •3. Patients must have received and failed therapy with ATRA and ATO either within the same or separate induction/consolidation schedule(s). Treatment must have been administered for a minimum of 28 days for each agent. Treatment may have been administered either as combination therapy or sequentially as single agents. Patients who failed to complete a course of induction/consolidation therapy, as specified, due to drug intolerance are eligible for the study.
• •4. Patients in whom ATO is contraindicated (for example due to congenital long QT syndrome) are eligible for inclusion on study if they have received and failed ATRA therapy as defined in (3).
• +28 more criteria