To hear about similar clinical trials, please enter your email below
Trial Title:
AIDA 2000 Guidelines
NCT ID:
NCT01064570
Condition:
Acute Promyelocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Promyelocytic, Acute
Tretinoin
Conditions: Keywords:
Acute Promyelocytic Leukemia
APL
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
all-trans retinoic acid (ATRA)
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:
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
Gender:
All
Minimum age:
1 Year
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Unità Operativa Ematologia 1 - Università degli Studi di Bari
Address:
City:
Bari
Zip:
70010
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Vincenzo LISO
Email:
v.liso@ematba.uniba.it
Facility:
Name:
Div. di Ematologia IRCCS Policlinico S. Matteo
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mario LAZZARINO
Email:
mlazzarino@smatteo.pv.it
Facility:
Name:
A.O Umberto I
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Franco MANDELLI, MD, PhD
Email:
gimema@gimema.it
Start date:
May 2000
Lead sponsor:
Agency:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Agency class:
Other
Source:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01064570
