None listed
Conditions
Interventions
Sponsors
INSTITUTO DE ENFERMEDADES NEOPLASICAS,
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female at least 2 years of age or older who have provided written informed consent. • In women of childbearing age (ie, excluding post-menopausal women and women who are surgically sterilized) adequate contraceptive methods should be used. Acceptable contraceptive methods are limited to oral contraceptives, implants, diaphragm, IUD or spermicide used with condoms. • Leukocyte count <10,000 / ul. • Life expectancy calculated equal to or greater than 8 weeks and a Zubrod score equal to or less than 3. • The patient could not have been treated by chemotherapy or radiotherapy during the four weeks prior to entering the study (with the exception of chemotherapy to treat leukocytosis). • There should be no evidence of residual toxic effects of previous chemotherapy treatments that may limit treatment. • Adequate liver function evidenced by a bilirubin equal to or less than 2.0 mg / dl and adequate renal function evidenced by a creatinine value of 2.0 mg / dl or less.
Exclusion criteria
Exclusion criteria: • Patients with newly diagnosed APL. • Pregnant or lactating woman. • Patients with clinically significant cardiac, renal or hepatic disease. • Patients who are already receiving treatment with retinoids such as Vitamin A at high doses. • Patients who require any chemotherapy simultaneously. • Patients with known hypersensitivity to retinoids or retinoic acid derivatives. • Patients who have been given another drug under study within 30 days before entering the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Bone marrow aspiration and hematological evaluations. Measure:Complete remission Timepoints:Before 3 days before the treatment and before 3 days of the last dose; and finally 3 days after finishing the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Complete hematological count with platelet count and formula. PT, PTT, fibrinogen, D-dimer Bone marrow aspirate Measure:Safety Timepoints:Complete hematological count at least 3 times a week during induction. PT, PTT, fibrinogen, D-dimer at least 3 times a week during the first 14 days of the induction and then only once a week until the end of the induction phase. Subsequently once a month during the post-induction phase. During the induction phase and the first months of the post-induction phase, bone marrow aspirates will be obtained. ; Outcome name:Chest x-ray and physical examination Measure:Incidence of ATRA syndrome Timepoints:Before 3 days before the treatment and before 3 days of the last dose. ; Outcome name:The disease-free state (DFS) in these patients will be evaluated during the Post-induction phase. Measure:Remission Duration Timepoints:In the Post-induction phase. | — |
Outcome results
None listed