AIDA Protocol (LAP 0493)

Study Overview
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Brief Summary
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The main purposes of the AIDA protocol are to test the role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at the end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase.

Official Title
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Guideline for the Treatment of Newly Diagnosed Patients Eith Acutypromyelocytic Leukemia, Aged > 12 Months (1 Year) and <75 Years, Using All-trans Retinoic Acid in Combination With Idarubicin

Conditions
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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 > 12 months (1 year) and < 75 years Morphological newly diagnosis of APL Presence of the PML-RARa transcript No cardiac contraindications to anthracycline chemotherapy Serum creatinine <=2.5 mg/dL Serum alkaline phosphatase <= 3 times the normal upper limit Serum bilirubin <= 3 times the normal upper limit Serum SGOT <= 3 times the upper normal limit Negative pregnancy test Informed consent Exclusion Criteria: Age <= 12 months and >=75 years absence of the PML-RARa transcript Pregnant of lactating women Presence of active serious infections that are not controlled by antibiotics Prior treatment with antileukemic therapy (excluded corticosteroids) Presence of severe concomitant psychiatric disease Presence of other concomitant malignant tumors, except basal cell carcinoma Concurrent treatment with cytotoxic chemotherapy or radiotherapy Cardiac contraindications to anthracycline chemotherapy Serum creatinine >2.5 mg/dL Serum alkaline phosphatase > 3 times the normal upper limit Serum bilirubin > 3 times the normal upper limit Serum SGOT > 3 times the upper normal limit Positive pregnancy test Absence of informed consent

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 75 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 |
| --- | --- | --- |
| To assess the role of maintenance therapy with ATRA, chemotherapy or both in PCR negative patients at the end of the consolidation phase. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase |  |  | 
| To evaluate the role of maintenance therapy with ATRA and chemotherapy in PCR positive patients at the end of the consolidation phase not eligible for a BMT procedure |  |  | 
| To assess the efficacy, in terms of CR rate, and toxicity of an induction treatment combining ATRA with Idarubicin |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute promyelocytic Leukemia