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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 67 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

Reduced intensity chemotherapy given with and without Imatinib Mesylate in patients >= 60 years considered unfit for standard chemotherapy with previously untreated Acute Myeloid Leukemia (AML) and refractory anemia with excess of Blasts (RAEB, RAEB-t)


Status

closed



Study details



Type of study

Prospective randomized Phase II study


Target number of patients

60


Date of activation

23-Jan-2006


Approved by

CKTO: June 27, 2005
MEC: METC Erasmus MC, August 29, 2005


Study objectives

Primary objective: To assess in a randomized comparison the effect of imatinib on the CR rate.
Secondary objectives:
1.To determine the efficacy profile (event free survival, disease free survival) and safety profile (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia)) associated with the two therapy regimens.
2.To measure MRD by immunophenotyping in relation to clinical response parameters.


2. Patient eligibility criteria



Inclusion criteria

Patients >= 60 years.
Patients considered unfit for standard chemotherapy.
Patients with a confirmed diagnosis of
a. AML FAB M0-M2 or M4–M7 (see 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 > 1.5
Subjects with secondary AML progressing from antecedent (at least 4 months duration) myelodysplasia are also eligible.
AST (SGOT) and ALT (SGPT), total serum bilirubin, serum creatinine, and creatinine clearance not more than 1.5 x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
Male patients agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following the discontinuation of study drug.
Written informed consent.


Exclusion criteria

Patients previously treated for AML (any antileukemic therapy including investigational agents)
Patients with cardiac dysfunction as defined by:
a. Myocardial infarction within the last 6 months prior to study entry
b. Reduced left ventricular ejection fraction of < 50% as evaluated by echocardiogram or MUGA scan
c. Unstable angina
d. Unstable cardiac arrhythmia
Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable
Patients with any serious concomitant medical condition, which could, in the opinion of the investigator, compromise participation in the study.
Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.


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:



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


4. Participating parties



Principal investigator

T. Fischer (t.fischer@3-med.klinik.uni-mainz.de)


Coordinating investigator(s)

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


Statistician(s)

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


Trial manager

S. Ramnarain (s.ramnarain@erasmusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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