MULTICENTRIC PHASE III STUDY DESIGNED TO EVALUATE ATRAGEN (LIPOSOMAL TRETINOIN ) IN THE TREATMENT OF PATIENTS WITH ACUTE PROMYELOCYTIC LEUKEMIA (APL) IN FIRST OR SUBSEQUENT RECIDIVES
- Conditions
- -C920 Acute myeloblastic leukaemia [AML]Acute myeloblastic leukaemia [AML]C920
- Registration Number
- PER-061-00
- Lead Sponsor
- INSTITUTO DE ENFERMEDADES NEOPLASICAS,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method