Acute Promyelocytic Leukemia
Conditions
Keywords
Acute Promyelocytic Leukemia, APL
Brief summary
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.
Interventions
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-related toxicity event rate during the ATRA-including consolidation treatment | At the end of the study |
Secondary
| Measure | Time frame |
|---|---|
| Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group | At the end of the study |
| The rates of molecular remission, after consolidation, in each risk group | At the end of the study |
| Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications | At the end of the study |
| The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group | At the end of the study |
| 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 | At the end of the study |
Countries
Italy
Outcome results
None listed