Clinical Trials /

AIDA 2000 Guidelines

NCT01064570

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: AIDA 2000 Guidelines
  • Official Title: Guidelines for Treatment of Acute Promyelocytic Leukemia

Clinical Trial IDs

  • ORG STUDY ID: AIDA2000
  • NCT ID: NCT01064570

Conditions

  • Acute Promyelocytic Leukemia

Interventions

DrugSynonymsArms
all-trans retinoic acid (ATRA)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        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
      
Maximum Eligible Age:60 Years
Minimum Eligible Age:1 Year
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Treatment-related toxicity event rate during the ATRA-including consolidation treatment
Time Frame:At the end of the study
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group
Time Frame:At the end of the study
Safety Issue:
Description:
Measure:The rates of molecular remission, after consolidation, in each risk group
Time Frame:At the end of the study
Safety Issue:
Description:
Measure:Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications
Time Frame:At the end of the study
Safety Issue:
Description:
Measure:The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group
Time Frame:At the end of the study
Safety Issue:
Description:
Measure:The impact on survival of a "total" treatment approach for APL including molecular evaluation of minimal residual disease and salvage tehrapy administration at the time of molecular or hematological relapse
Time Frame:At the end of the study
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Gruppo Italiano Malattie EMatologiche dell'Adulto

Trial Keywords

  • Acute Promyelocytic Leukemia
  • APL

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