Description:
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.
Title
- Brief Title: "AIDA" Protocol (LAP 0493)
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
AIDA0493
- NCT ID:
NCT01064557
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| all-trans retinoic acid (ATRA) | | |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
Eligibility Criteria
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
| Maximum Eligible Age: | 75 Years |
| Minimum Eligible Age: | 1 Year |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | To assess the role of maintenance therapy with ATRA, chemotherapy or both in PCR negative patients at the end of the consolidation phase. |
| Time Frame: | |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | To assess the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase |
| Time Frame: | |
| Safety Issue: | |
| Description: | |
| Measure: | 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 |
| Time Frame: | |
| Safety Issue: | |
| Description: | |
| Measure: | To assess the efficacy, in terms of CR rate, and toxicity of an induction treatment combining ATRA with Idarubicin |
| Time Frame: | |
| Safety Issue: | |
| Description: | |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
Trial Keywords
- Acute promyelocytic Leukemia
Last Updated
October 14, 2020
