AIDA 2000 Guidelines
Phase 2
- Conditions
- Acute Promyelocytic Leukemia
- Registration Number
- NCT01064570
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Treatment-related toxicity event rate during the ATRA-including consolidation treatment At the end of the study
- Secondary Outcome Measures
Name Time Method 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 The rates of molecular remission, after consolidation, in each risk group At the end of the study Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival 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
Trial Locations
- Locations (3)
A.O Umberto I
🇮🇹Roma, Italy
Unità Operativa Ematologia 1 - Università degli Studi di Bari
🇮🇹Bari, Italy
Div. di Ematologia IRCCS Policlinico S. Matteo
🇮🇹Pavia, Italy