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AIDA 2000 Guidelines
Conditions
Acute Promyelocytic Leukemia
Conditions: official terms
Leukemia, Promyelocytic, Acute
Conditions: Keywords
Acute Promyelocytic Leukemia, APL
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: all-trans retinoic acid (ATRA)
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 1 Year
Gender: Both
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
- 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
Locations
Unità Operativa Ematologia 1 - Università degli Studi di Bari
Bari, Italy
Div. di Ematologia IRCCS Policlinico S. Matteo
Status: Recruiting
Contact: Vincenzo LISO - v.liso@ematba.uniba.it
Pavia, Italy
A.O Umberto I
Status: Recruiting
Contact: Mario LAZZARINO - mlazzarino@smatteo.pv.it
Roma, Italy
Status: Recruiting
Contact: Franco MANDELLI, MD, PhD - gimema@gimema.it
Start Date
May 2000
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Source
Gruppo Italiano Malattie EMatologiche dell'Adulto
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page