Clinical Trials /

"AIDA" Protocol (LAP 0493)

NCT01064557

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: "AIDA" Protocol (LAP 0493)
  • 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

Clinical Trial IDs

  • ORG STUDY ID: AIDA0493
  • NCT ID: NCT01064557

Conditions

  • Leukemia

Interventions

DrugSynonymsArms
all-trans retinoic acid (ATRA)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions

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
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:1 Year
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To assess the role of maintenance therapy with ATRA, chemotherapy or both in PCR negative patients at the end of the consolidation phase.
Time Frame:
Safety Issue:
Description:

Secondary Outcome Measures

Measure:To assess the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase
Time Frame:
Safety Issue:
Description:
Measure: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
Time Frame:
Safety Issue:
Description:
Measure:To assess the efficacy, in terms of CR rate, and toxicity of an induction treatment combining ATRA with Idarubicin
Time Frame:
Safety Issue:
Description:

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Gruppo Italiano Malattie EMatologiche dell'Adulto

Trial Keywords

  • Acute promyelocytic Leukemia

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