Clinical trial · Interventional
AIDA 2000 Guidelines
Guidelines for Treatment of Acute Promyelocytic Leukemia
NCT01064570CI-TRIAL-00047659unknownPhase 2ClinicalTrials.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)
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.
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 |
|---|---|---|---|
| Acute Promyelocytic Leukemia | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
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
- Treatment-related toxicity event rate during the ATRA-including consolidation treatment
- timeFrame
- At the end of the study
Secondary outcomes (5)
- measure
- Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group
- timeFrame
- At the end of the study
- measure
- The rates of molecular remission, after consolidation, in each risk group
- timeFrame
- At the end of the study
- measure
- Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications
- timeFrame
- At the end of the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDBreccia M, Mazzarella L, Bagnardi V, Disalvatore D, Loglisci G, Cimino G, Testi AM, Avvisati G, Petti MC, Minotti C, Latagliata R, Foa R, Pelicci PG, Lo-Coco F. Increased BMI correlates with higher risk of disease relapse and differentiation syndrome in patients with acute promyelocytic leukemia treated with the AIDA protocols. Blood. 2012 Jan 5;119(1):49-54. doi: 10.1182/blood-2011-07-369595. Epub 2011 Nov 2. PMID 22049518
- RESULTLo-Coco F, Avvisati G, Vignetti M, Breccia M, Gallo E, Rambaldi A, Paoloni F, Fioritoni G, Ferrara F, Specchia G, Cimino G, Diverio D, Borlenghi E, Martinelli G, Di Raimondo F, Di Bona E, Fazi P, Peta A, Bosi A, Carella AM, Fabbiano F, Pogliani EM, Petti MC, Amadori S, Mandelli F; Italian GIMEMA Cooperative Group. Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years: results of the AIDA-2000 trial of the GIMEMA Group. Blood. 2010 Oct 28;116(17):3171-9. doi: 10.1182/blood-2010-03-276196. Epub 2010 Jul 19. PMID 20644121