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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 42 A AML / SAKK


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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1. Overview



Summary

Randomized induction concerning the value of G-CSF priming in adult patients (<=60 years of age) with acute myelocytic leukemia (AML) or refractory anemia with excess of blasts (RAEB, RAEB-t) with IPSS score >=1.5


Status

closed



Study details



Type of study

Prospective randomized Phase III study


Target number of patients

1440


Date of activation

02-Jan-2001


Date closed

15-Oct-2008


Approved by

CKVO: CKVO 2000-08
MEC: METC EUR/AZR, 29 November 2000


Change history / amendement

this is amendment 5 of the HOVON / SAKK AML -42 protocol


Study objectives

To study in a randomized comparison the use of granulocyte-colony stimulating factor (G-CSF) for priming during induction cycles I and II as regards the complete remission rate, disease free survival, risk of relapse and overall survival.
To evaluate the outcome of allogeneic sibling SCT in intermediate risk patients and compare the results with those after chemotherapy and ablation + PBSCT
To assess the value of early allogeneic family donor and unrelated donor SCT in patients with poor risk AML in comparison to the results in those treated with chemotherapy and ablation + PBSCT
To determine the prognostic value of molecular markers and gene expression profiles of the leukemia assessed at diagnosis
To assess minimal residual disease following therapy by standardized sampling of marrow/blood


2. Patient eligibility criteria



Inclusion criteria

Age 18-60 years (incl.)
Subjects with a cytopathologically confirmed diagnosis of (a) AML (M0-M2 and M4-M7, FAB classification, appendix A), or (b) with refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >1.5 (appendix B)
Patients with therapy-related AML/RAEB/RAEB-t are eligible provided they have not received chemotherapy during the past 6 months. Also patients with biphenotypic leukemia may be included.
Subjects with a secondary AML progressing from antecedent myelodysplasia are eligible. Antecedent MDS refers to a condition of at least 4 month duration
WHO performance status <= 2 (see appendix E)
Written informed consent


Exclusion criteria

Prior chemotherapy within 6 months of study entry
Relapse of AML or MDS after induction chemotherapy
Prior stem cell transplant
Previous polycythemia rubra vera
Primary myelofibrosis
Blast crisis of chronic myeloid leukemia
AML-FAB type M3 or AML with cytogenetic abnormality t(15;17) or AML with a PML/RAR alpha or a variant RAR alpha fusion gene
Impaired hepatic or renal function as defined by: ALT and/or AST > 3 x normal value Bilirubin > 3 x normal value Serum creatinin > 3 x normal value (after adequate hydration),(unless these are most likely caused by AML organ infiltration)
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.)
Cardiac dysfunction as defined by: Myocardial infarction within the last 6 months of study entry, or Reduced left ventricular function with an ejection fraction <50% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable) Unstable angina Unstable cardiac arrhythmias
Pregnancy


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:



Name institute
Name of caller/physician who treats the patient
Patient's initials or code
Patient's hospital record number
Sex
Date of birth
Date of diagnosis of AML or RAEB or RAEB-t
WHO performance status
FAB type of AML or RAEB or RAEB-t
Eligibility criteria
Prior hematological or oncological disease
Previous chemotherapy or radiotherapy
Consent for additional cell, DNA/RNA and protein analysis
WBC at diagnosis (10^9/l)


4. Participating parties



Principal investigator

B. Lowenberg (b.lowenberg@erasmusmc.nl)


Coordinating investigator(s)

M.A. Boogaerts
E. Vellenga
J. Gmür
T. Pabst


Statistician(s)

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


Trial manager

I. Meulendijks (l.meulendijks@erasmusmc.nl)


Central data management

J. van Tuijn (j.vantuijn@erasmusmc.nl)
R. Hollestein (r.hollestein@erasmusmc.nl)
H.Visser-Wisselaar (h.visser-wisselaar@erasmusmc.nl@erasmusmc.nl)


Other functions

Central Cytogeneticist:
B. Beverloo (b.beverloo@erasmusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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