Main info

Identifier:

HOVON 52 AML

Sponsor:

HOVON

Included patients:

506

Active sites:

0

(of 1)

13 sites are pending

Title:

Treatment of Acute Promyelocytic Leukemia: Remission Induction with ATRA+Idarubicin (AIDA). Risk Adapted Intensity of Consolidation and Addition of ATRA Maintenance with ATRA + Methotrexate + Mercaptopurine Rescue Therapy for Molecular and Haematological Relapses.

Timeline

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Age 18-75 years, inclusive;
• ECOG Performance status <= 3;
• Morphological diagnosis of M3 or M3v. Those cases without typical morphology but with PML-RARa rearrangement may also be included;
• Genetic diagnosis: t(15;17), PML-RARa rearrangement, monoclonal anti-PML positive. Obviously, the result of these tests may become available after having initiated the treatment based on a tentative morphological diagnosis. The presence of secondary cytogenetic changes associated with t(15;17) is not a reason for exclusion nor do they require a different therapeutic approach;
• Written informed consent.

Exclusion Criteria:

• Age >75 years (the treatment with this protocol can be considered on an individual basis but these patients will be analysed separately);
• Absence of PML-RARa rearrangement;
• Prior antileukemic chemotherapy;
• Presence of an associated neoplasm;
• Presence of a severe psychiatric disease;
• HIV seropositivity;
• Contraindication for intensive chemotherapy, especially to anthracyclines;
• Serum creatinine >= 2.5 mg/dL;
• Bilirubin, alkaline phosphatase, or SGOT > 3 times the upper normal limit;
• Positive pregnancy test;

Participating Sites

= Active hospitals

= Inactive hospitals