Clinical trial · Interventional
"AIDA" Protocol (LAP 0493)
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
NCT01064557CI-TRIAL-00047673unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| all-trans retinoic acid (ATRA) | Drug | Tretinoin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the role of maintenance therapy with ATRA, chemotherapy or both in PCR negative patients at the end of the consolidation phase.
Secondary outcomes (3)
- measure
- To assess the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase
- 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
- measure
- To assess the efficacy, in terms of CR rate, and toxicity of an induction treatment combining ATRA with Idarubicin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDAvvisati G, Lo Coco F, Diverio D, Falda M, Ferrara F, Lazzarino M, Russo D, Petti MC, Mandelli F. AIDA (all-trans retinoic acid + idarubicin) in newly diagnosed acute promyelocytic leukemia: a Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) pilot study. Blood. 1996 Aug 15;88(4):1390-8. PMID 8695858
- RESULTAvvisati G, Lo-Coco F, Paoloni FP, Petti MC, Diverio D, Vignetti M, Latagliata R, Specchia G, Baccarani M, Di Bona E, Fioritoni G, Marmont F, Rambaldi A, Di Raimondo F, Kropp MG, Pizzolo G, Pogliani EM, Rossi G, Cantore N, Nobile F, Gabbas A, Ferrara F, Fazi P, Amadori S, Mandelli F; GIMEMA, AIEOP, and EORTC Cooperative Groups. AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance. Blood. 2011 May 5;117(18):4716-25. doi: 10.1182/blood-2010-08-302950. Epub 2011 Mar 8. PMID 21385856
- RESULTLatagliata R, Breccia M, Fazi P, Vignetti M, Di Raimondo F, Sborgia M, Vincelli D, Candoni A, Salvi F, Rupoli S, Martinelli G, Kropp MG, Tonso A, Venditti A, Melillo L, Cimino G, Petti MC, Avvisati G, Lo-Coco F, Mandelli F; GIMEMA Acute Leukaemia Working Party. GIMEMA AIDA 0493 amended protocol for elderly patients with acute promyelocytic leukaemia. Long-term results and prognostic factors. Br J Haematol. 2011 Sep;154(5):564-8. doi: 10.1111/j.1365-2141.2011.08593.x. Epub 2011 Jul 14. PMID 21751984