AIDA Protocol (LAP 0493)

Guideline for the Treatment of Newly Diagnosed Patients Eith Acutypromyelocytic Leukemia, Aged > 12 Months (1 Year) and <75 Years, Using All-trans Retinoic Acid in Combination With Idarubicin

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01064557

Enrollment

1068

Registered

2010-02-08

Start date

1993-10-31

Completion date

2020-12-31

Last updated

2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

Acute promyelocytic Leukemia

Brief summary

The main purposes of the AIDA protocol are to test the role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at the end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase.

Interventions

DRUGall-trans retinoic acid (ATRA)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Age \> 12 months (1 year) and \< 75 years * Morphological newly diagnosis of APL * Presence of the PML-RARa transcript * No cardiac contraindications to anthracycline chemotherapy * Serum creatinine \<=2.5 mg/dL * Serum alkaline phosphatase \<= 3 times the normal upper limit * Serum bilirubin \<= 3 times the normal upper limit * Serum SGOT \<= 3 times the upper normal limit * Negative pregnancy test * Informed consent

Exclusion criteria

* Age \<= 12 months and \>=75 years * absence of the PML-RARa transcript * Pregnant of lactating women * Presence of active serious infections that are not controlled by antibiotics * Prior treatment with antileukemic therapy (excluded corticosteroids) * Presence of severe concomitant psychiatric disease * Presence of other concomitant malignant tumors, except basal cell carcinoma * Concurrent treatment with cytotoxic chemotherapy or radiotherapy * Cardiac contraindications to anthracycline chemotherapy * Serum creatinine \>2.5 mg/dL * Serum alkaline phosphatase \> 3 times the normal upper limit * Serum bilirubin \> 3 times the normal upper limit * Serum SGOT \> 3 times the upper normal limit * Positive pregnancy test * Absence of informed consent

Design outcomes

Primary

Measure	Time frame
To assess the role of maintenance therapy with ATRA, chemotherapy or both in PCR negative patients at the end of the consolidation phase.	—

Secondary

Measure	Time frame
To assess the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase	—
To evaluate the role of maintenance therapy with ATRA and chemotherapy in PCR positive patients at the end of the consolidation phase not eligible for a BMT procedure	—
To assess the efficacy, in terms of CR rate, and toxicity of an induction treatment combining ATRA with Idarubicin	—

Countries

Belgium, Germany, Italy, Netherlands, Turkey (Türkiye)

Contacts

Primary ContactPaola Fazi

p.fazi@gimema.it

Backup ContactEnrico Crea

e.crea@gimema.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026