Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
600 participants
INTERVENTIONAL
2000-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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all-trans retinoic acid (ATRA)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
60 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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GIMEMA
Locations
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Unità Operativa Ematologia 1 - Università degli Studi di Bari
Bari, , Italy
Div. di Ematologia IRCCS Policlinico S. Matteo
Pavia, , Italy
A.O Umberto I
Roma, , Italy
Countries
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Facility Contacts
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References
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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.
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.
Other Identifiers
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AIDA2000
Identifier Type: -
Identifier Source: org_study_id
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