Clinical trial NCT01064570: AIDA 2000 Guidelines
Official title: Guidelines for Treatment of Acute Promyelocytic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Promyelocytic Leukemia
Keywords: Acute Promyelocytic Leukemia
APL
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2010-02-08
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment-related toxicity event rate during the ATRA-including consolidation treatment
timeFrame: At the end of the study
Secondary outcomes:
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
measure: The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group
timeFrame: At the end of the study
measure: 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
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Unità Operativa Ematologia 1 - Università degli Studi di Bari
city: Pavia
country: Italy
facility: Div. di Ematologia IRCCS Policlinico S. Matteo
city: Roma
country: Italy
facility: A.O Umberto I
Study officials:
References:
citation: Breccia 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.
citation: Lo-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.