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.
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
Drug | Synonyms | Arms |
---|
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
Name | Type | Description | Interventions |
---|
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
Last Updated
October 14, 2020