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Prospective use of RT-PCR for PML/RARa might be used to guide a total tehrapy approach in APL, including refined diagnosis, front-line treatment, assessment of response and anticipated salvage therapy for patients who undergo molecular relapse.
Treatment-related toxicity event rate during the ATRA-including consolidation treatment [ Time Frame: At the end of the study ]
Secondary Outcome Measures
Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group [ Time Frame: At the end of the study ]
The rates of molecular remission, after consolidation, in each risk group [ Time Frame: At the end of the study ]
Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications [ Time Frame: At the end of the study ]
The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group [ Time Frame: At the end of the study ]
The impact on survival of a "total" treatment approach for APL including molecular evaluation of minimal residual disease and salvage tehrapy administration at the time of molecular or hematological relapse [ Time Frame: At the end of the study ]
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Ages Eligible for Study:
1 Year to 60 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age >= 1 years and < 61 years
Morphologic diagnosis of APL
PS <= 3
Presence in leukemic cells at diagnosis of t(15;17), and/or PML/RARa rearrangement by RT-PCR. T
The presence of additional cytogenetic lesions is not considered an exclusion criterion
Serum creatinine <=2.5 mg/dL
Serum bilirubin, alkaline phosphatase, or GOT/ASAT <= 3 times the upper normal limit
Negative pregnancy test
Written informed consent
Age >= 61 years
Prior antileukemic chemotherapy for APL
Absence of PML-RARa rearrangement after successful RNA extraction and amplification of control gene
Prior antileikemic chemotherapy for APL
Presence of a concomitant malignant neoplasm, except basal cell carcinoma Concurrent treatment with cytotoxic chemotherapy or radiotherapy
Oteher progressive malignant disease. However, secondary acute promyelocytic leukemia following "cured" Hodgkin's disease or otehr cured malignancies may be included, as well as secondary leukemias following other exposure to alkylating agents or radiation for other reasons