AIDA 2000 Guidelines

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status and phase

Unknown

Phase 2

Conditions

Acute Promyelocytic Leukemia

Treatments

Drug: all-trans retinoic acid (ATRA)

Study type

Interventional

Funder types

Other

Identifiers

NCT01064570

AIDA2000

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

1 to 60 years old

Volunteers

No 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