AIDA 2000 Guidelines

Phase 2

• Conditions: Acute Promyelocytic Leukemia

• Registration Number: NCT01064570
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment-related toxicity event rate during the ATRA-including consolidation treatment	At the end of the study

Secondary Outcome Measures

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

Trial Locations

Locations (3)

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