AIDA 2000 Guidelines

Study Overview
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Brief Summary
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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.

Official Title
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Guidelines for Treatment of Acute Promyelocytic Leukemia

Conditions
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Acute Promyelocytic Leukemia

Intervention / Treatment
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* Drug: all-trans retinoic acid (ATRA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: all-trans retinoic acid (ATRA)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related toxicity event rate during the ATRA-including consolidation treatment |  | At the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group |  | At the end of the study | 
| The rates of molecular remission, after consolidation, in each risk group |  | At the end of the study | 
| Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications |  | At the end of the study | 
| The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group |  | 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 |  | At the end of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Promyelocytic Leukemia, APL