A Phase 4 interventional study of AIDA in Acute Promyelocytic Leukemia, sponsored by PETHEMA Foundation. Completed at 2 sites in Spain. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2008-03-31.
Sponsored by PETHEMA Foundation · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of all-trans retinoic acid (ATRA) and idarubicin (AIDA) with a dose reduction in patients older than 70 years of age in the remission induction of acute promyelocytic leukemia (APL).
With regard to the induction, the excellent results obtained by the combination of ATRA and idarubicin (AIDA), especially in terms of antileukemic efficacy (1% of resistance), do not support the introduction of substantial changes in this combination. However, given that most of the induction failures were caused by complications, especially of a hemorrhagic nature, and that these had a major impact in the hyperleukocytic forms and in patients older than 70 years of age, the induction was modified as follows:
Induction chemotherapy:
All-trans retinoic acid, will be administered by mouth (PO) from the first day at a dose of 45 mg/m²/day, fractionated into 2 doses.
In patients aged \< 20 years, the ATRA dose will be reduced to 25 mg/m²/day fractionated into 2 doses.
The treatment with ATRA will continue until a CR is achieved or for a maximum of 90 days in the case of persistence of atypical promyelocytes in the bone marrow.
Idarubicin, 12 mg/m² on days 2, 4, 6 and 8 of treatment by slow intravenous infusion (20 minutes).
In patients older than 70 years of age only 3 doses of idarubicin will be given on days 2, 4, and 6.
Supporting measures:
Prednisone, 0.5 mg/kg/day days 1 to 15. Tranexamic acid, 100 mg/kg/day in continuous perfusion, if platelets \< 50 x 10\^9/L or evident clinical-biological signs of coagulopathy. This treatment will be discontinued if the platelet counts are > 50 x 10\^9/L.
Transfusion of platelet concentrates to keep up counts above 30 x 10\^9/L during the first 10 days and PRC to maintain hemoglobin levels greater than 9 g/dL.
Prophylactic heparin should not be used.
110 studies on the registry are indexed under Leukemia, Promyelocytic, Acute; 17 are open to participants now.
Browse Leukemia, Promyelocytic, Acute studies →PETHEMA Foundation is the lead sponsor of 106 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
To evaluate the efficacy of AIDA with a dose reduction in patients older than 70 years of age in the remission induction of APL
Time frame: 6 months
To evaluate the impact on morbidity and mortality of the prophylactic measures included in induction therapy (low dose prednisone and tranexamic acid)
Time frame: 1 year
To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy
Time frame: 2 years
To evaluate the impact on the event free survival, disease free survival and global survival in each relapse risk group
Time frame: 5 years
To evaluate the rates of molecular remission (PML/RARa negative by RT-PCR) in the successive therapeutic phases with special emphasis on patients with a higher risk for relapse
Time frame: 2 years
The record gives a start of Mar 1999, a primary completion of Aug 2007 and a completion of Nov 2007. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Leukemia, Promyelocytic, Acute →