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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 52 AML


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


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1. Overview



Summary

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


Status

closed



Study details



Type of study

Prospective Phase II study


Target number of patients

15


Date of activation

07-Dec-2001


Approved by

MEC: METC AZG 2001/140c, 24 August 2001


2. Patient eligibility criteria



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;


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Patient�s initials or code
Patient�s hospital record number
Sex
Date of birth
Date of diagnosis of AML
Eligibility criteria


4. Participating parties



Principal investigator

E. Vellenga (E.Vellenga@int.azg.nl)


Coordinating investigator(s)

B. L�wenberg (b.lowenberg@erasmusmc.nl)


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)


Trial manager

F. Spoelstra (f.spoelstra@erasmusmc.nl)


Central data management

F. Spoelstra (f.spoelstra@erasmusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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