AIDA 2000 Guidelines

Acute Promyelocytic Leukemia Clinical Trial

Official title:

Guidelines for Treatment of Acute Promyelocytic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01064570
• Other study ID #: AIDA2000
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2000

Study information

• Verified date: October 2020
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Promyelocytic Leukemia
• Leukemia
• Leukemia, Promyelocytic, Acute

Intervention

Drug:
• all-trans retinoic acid (ATRA)

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Breccia M, Mazzarella L, Bagnardi V, Disalvatore D, Loglisci G, Cimino G, Testi AM, Avvisati G, Petti MC, Minotti C, Latagliata R, Foà 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related toxicity event rate during the ATRA-including consolidation treatment		At the end of the study
Secondary	Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group		At the end of the study
Secondary	The rates of molecular remission, after consolidation, in each risk group		At the end of the study
Secondary	Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications		At the end of the study
Secondary	The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group		At the end of the study
Secondary	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		At the end of the study