|
|
- Patients with secondary APL are excluded, this includes all patients with APL that may have resulted from prior treatment (chemotherapy or radiation)
|
- Patients with isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) but without evidence of APL by bone marrow or peripheral blood morphology are excluded
|
- Patients with a pre-existing diagnosis of a prolonged QT syndrome (even if corrected QT interval \[QTc\] is normal at the time of APL diagnosis) are excluded
|
- Patients with a baseline QTc of \> 450 msec are excluded
|
- Bazett's formula is to be used for measurement of the corrected QT interval: the QT interval (msec) divided by the square root of the RR interval (msec)
|
- Patients with a history or presence of significant ventricular or atrial tachyarrhythmia are excluded
|
- Patients with right bundle branch block plus left anterior hemiblock, bifascicular block are excluded
|
- Patients with serum creatinine \> 3.0 mg/dL and patients on active dialysis for renal dysfunction are excluded
|
- Patients who have received treatment with any other cytotoxic chemotherapy prior to beginning protocol therapy (other than allowed in above criteria) are excluded
|
- Female patients who are pregnant are excluded, patients should not be pregnant or plan to become pregnant while on treatment, a pregnancy test prior to enrollment is required for female patients of childbearing potential
|
- Lactating females who plan to breastfeed their infants are excluded
|
- Sexually active patients of reproductive potential who have not agreed to be abstinent or use 2 forms of effective contraception during treatment through 1 month off therapy are excluded
|