None listed
Conditions
Interventions
Sponsors
INSTITUTO DE ENFERMEDADES NEOPLASICAS,
Eligibility
Inclusion criteria
Inclusion criteria: • Men or women at least 2 years of age or older who have provided written informed consent • Appropriate contraceptive methods should be used for women of childbearing age (ie, excluding post-menopausal women and women who are surgically sterilized). Acceptable contraceptive methods are limited to oral contraceptives, implants, diaphragm, IUD or spermicide used with condoms. • Leukocyte count 10,000 / ul, hydroxyurea should be administered to try to reduce the leukocyte count effectively to <10,000 / ul. But if a patient presents the urgent need to receive treatment, the patient may initiate the treatment at the discretion of the researcher regardless of the leukocyte count. • Life expectancy calculated 8 weeks and a score of Zubrod 3 • Corticoid treatment should not be administered prior to treatment unless the previous state indicates otherwise. Prior treatment for the prophylaxis of ATRA syndrome is not allowed. • Adequate liver function evidenced by a bilirubin 2.0 mg / dl and some transaminases, that is, SGPT / SGOT <3 x upper limit of normality, as well as an adequate renal function evidenced by a creatinine value 2.0 mg / dl.
Exclusion criteria
Exclusion criteria: • Patients with newly diagnosed APL. • Pregnant or lactating woman. • Patients with clinically significant cardiac, renal or hepatic disease that would exclude them from treatment with retinoids. • Patients who are already receiving treatment with retinoids, such as Vitamin A at high doses. • Patients who require any chemotherapy at the same time (different to the one previously described). • Patients with known hypersensitivity to retinoids or retinoic acid derivatives. • Patients who have been given another study drug in a 30-day period before entering the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Bone marrow aspiration and hematological evaluations. It is defined as follows: a morphologically normal bone marrow with 100,000, and a neutrophil count> 1,000 with no clinical or laboratory evidence of disseminated intravascular coagulation. Measure:Complete referral 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:The duration of remission of disease-free status (DFS) in these patients will be evaluated during the Post-induction phase. Measure:Remission Duration Timepoints:In the Post-induction phase. ; 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. | — |
Countries
Spain
Outcome results
None listed