None listed
Conditions
Interventions
The initial dose will be 90 mg / m2 I.V. for 0.5 hours every other day for all patients until full remission is reached (up to 56 days from the start of treatment). Depending on the level of toxicity observed and the level of documented response, the study drug will be maintained at 90 mg / m2, will be decreased by 25%, will be increased to 110 mg / m2 or its use will be discontinued. During the Post-induction phase, the dose of Atragen will be maintained at the final dose during the induction,
Sponsors
INSTITUTO DE ENFERMEDADES NEOPLASICAS,
Eligibility
Inclusion criteria
Inclusion criteria: • Men or women at least 18 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:The proportion of patients who achieve complete remission. Measure:Proportion of patients who achieve 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:Hematological and biochemical analysis, evaluated according to the NCI toxicity criteria. Measure:Safety Timepoints:Every 2 weeks during the induction and 1-3 days from the final dose. ; Outcome name:Time needed to achieve complete remission in patients treated with Atragen. The duration of remission of disease-free status (DFS) in these patients will be evaluated during the Post-induction phase. Measure:Remission Duration Timepoints:8 weeks | — |
Countries
Spain
Outcome results
None listed