"AIDA" Protocol (LAP 0493)

ClinicalTrials.gov ID

NCT01064557

Lead Sponsor

Gruppo Italiano Malattie EMatologiche dell'AdultoOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,068Estimated

Last Update Posted

Oct 14, 2020Actual

Start Date

Oct 1993

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

Official Title

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

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.

• Leukemia

• all-trans retinoic acid (ATRA)

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Gruppo Italiano Malattie EMatologiche dell'AdultoOTHER

gimema@gimema.it

francesco.lo.coco@uniroma2.it

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