A PHASE II MULTICENTRIC STUDY DESIGNED TO EVALUATE ATRAGEN (LIPOSOMAL TRETINOIN ) COMPASSIVE USE IN THE TREATMENT OF PATIENTS WITH ACUTE PROMYELOCYTIC LEUKEMIA (APL)
- Conditions
- -C920 Acute myeloblastic leukaemia [AML]Acute myeloblastic leukaemia [AML]C920
- Registration Number
- PER-063-00
- 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 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 prior to starting the administration of Atragen.
• Typically, patients will present with leukopenia; however, in cases of patients with leukoclonal counts> 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method