"AIDA" Protocol (LAP 0493)

Not Applicable

• Conditions: Leukemia

• Registration Number: NCT01064557
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1993-10
• 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
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1068

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
To assess the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase

Trial Locations

Locations (80)

Department of Hematology - Middelheim Ziekenhuis; 🇧🇪 Antwerpen, Belgium

Department of Hematology - Klinikum Grosshadem - Ludwig Maxmilians; 🇩🇪 Munchen, Germany

S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Italy

Azienda Ospedaliera - Nuovo Ospedale "Torrette"; 🇮🇹 Ancona, Italy

U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno; 🇮🇹 Ascoli, Italy

Az.Ospedaliera S.G.Moscati; 🇮🇹 Avellino, Italy

Centro di Riferimento Oncologico; 🇮🇹 Aviano, Italy

Unità Operativa Ematologia 1 - Università degli Studi di Bari; 🇮🇹 Bari, Italy

Ematologia con trapianto-Università degli Studi di Bari Aldo Moro; 🇮🇹 Bari, Italy

Azienda Ospedaliera - Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

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