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AIDA 2000 Guidelines

Primary Purpose

Acute Promyelocytic Leukemia

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
all-trans retinoic acid (ATRA)
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Promyelocytic Leukemia focused on measuring Acute Promyelocytic Leukemia, APL

Eligibility Criteria

1 Year - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unità Operativa Ematologia 1 - Università degli Studi di BariRecruiting
  • Div. di Ematologia IRCCS Policlinico S. MatteoRecruiting
  • A.O Umberto IRecruiting

Outcomes

Primary Outcome Measures

Treatment-related toxicity event rate during the ATRA-including consolidation treatment

Secondary Outcome Measures

Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group
The rates of molecular remission, after consolidation, in each risk group
Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications
The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group
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

Full Information

First Posted
February 5, 2010
Last Updated
October 12, 2020
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT01064570
Brief Title
AIDA 2000 Guidelines
Official Title
Guidelines for Treatment of Acute Promyelocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Promyelocytic Leukemia
Keywords
Acute Promyelocytic Leukemia, APL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
all-trans retinoic acid (ATRA)
Primary Outcome Measure Information:
Title
Treatment-related toxicity event rate during the ATRA-including consolidation treatment
Time Frame
At the end of the study
Secondary Outcome Measure Information:
Title
Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group
Time Frame
At the end of the study
Title
The rates of molecular remission, after consolidation, in each risk group
Time Frame
At the end of the study
Title
Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications
Time Frame
At the end of the study
Title
The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group
Time Frame
At the end of the study
Title
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
Time Frame
At the end of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Unità Operativa Ematologia 1 - Università degli Studi di Bari
City
Bari
ZIP/Postal Code
70010
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo LISO
Email
v.liso@ematba.uniba.it
Facility Name
Div. di Ematologia IRCCS Policlinico S. Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario LAZZARINO
Email
mlazzarino@smatteo.pv.it
Facility Name
A.O Umberto I
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco MANDELLI, MD, PhD
Email
gimema@gimema.it

12. IPD Sharing Statement

Citations:
PubMed Identifier
22049518
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.
Results Reference
background
PubMed Identifier
20644121
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.
Results Reference
result

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AIDA 2000 Guidelines

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