HOVON HO52

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Main info

Identificatie:
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

Scheduled
Actual
2001
07 dec.
Activated
2020
22 okt.
Archived

Flow

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

Site
13 results
Order by
Accrual rate
Activation date
NL-Groningen-UMCG
9
BE-Leuven-UZLEUVEN
8
NL-Rotterdam-ERASMUSMC
8
NL-Rotterdam-EMCDANIEL
8
NL-Amsterdam-AMC
6
NL-Den Haag-HAGA
4
NL-Amsterdam-VUMC
4
NL-Zwolle-ISALA
2
NL-Nieuwegein-ANTONIUS
1
NL-Amsterdam-OLVG
1
NL-Maastricht-MUMC
1
NL-Enschede-MST
1
HOVON Data Center
= Active hospitals
= Inactive hospitals

Participating Parties

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