Contact information
Type
Scientific
Primary contact
Prof B. Löwenberg
ORCID ID
Contact details
Erasmus Medical Center
Daniel den Hoed Cancer Center
Department of Hematology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 4391598
b.lowenberg@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HO67
Study information
Scientific title
Acronym
HOVON / SAKK AML - 67
Study hypothesis
The hypothesis to be tested is that the outcome in arm 2 is better than in arm 1.
Ethics approval
Not provided at time of registration
Study design
Randomized phase II study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Acute myeloid leukemia (AML)
Intervention
The reduced intensity chemotherapy will consist of one induction cycle (cycle I) followed by one cycle of consolidation (cycle II).
The chemotherapy regimen for induction is as follows:
1. Ara-C 100 mg/m^2/day continuous intravenous (iv) infusion, days 1-5
2. Daunorubicin (DNR) 45 mg/m^2/day iv 3h, days 1-2
The chemotherapy regimen for consolidation is as follows:
1. Ara-C 100 mg/m^2/day iv continuous infusion, days 1-5
2. Daunorubicin (DNR) 45 mg/m^2/day iv 3h, days 1-2
Patients assigned to the imatinib arm, in addition will receive a daily dose of 600 mg imatinib orally (p.o.) from day 1 of the chemotherapy cycle till the end of week 40 (or until disease progression [death], or in case of no complete remission (CR) or no partial remission (PR) after cycle I or II.)
Intervention type
Drug
Phase
Phase II
Drug names
Imatinib mesylate
Primary outcome measures
Complete remission (CR) rate
Secondary outcome measures
1. Overall survival (time from registration till the death of the patient)
2. Event free survival (i.e. time from registration to induction failure, death or disease progression, whichever occurs first)
3. Adverse events or toxicity.
Overall trial start date
23/01/2006
Overall trial end date
01/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients >/= 60 years
2. Patients considered unfit for standard chemotherapy
3. Patients with a confirmed diagnosis of
a. Acute myeloid leukemia (M0-M2 and M4-M7, FAB classification)
b. With refractory anemia with excess of blasts (RAEB) or refractory anemia with
excess of blasts in transformation (RAEB-T) with an International Prognostic Scoring System (IPSS) score >/= 1.5
4. Subjects with secondary AML progressing from antecedent (at least 4 months duration) myelodysplasia are also eligible
5. Serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT), total serum bilirubin, serum creatinine, and creatinine clearance not more than 1.5 x the upper limit of normal (ULN) at the laboratory where the analyses were performed
6. Male patients agree to employ an effective barrier method of birth control throughout the study and for up to three months following the discontinuation of study drug
7. Written informed consent
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Patients previously treated for AML (any antileukemic therapy including investigational agents)
2. Patients with cardiac dysfunction as defined by:
a. Myocardial infarction within the last six months prior to study entry
b. Reduced left ventricular ejection fraction of <50% as evaluated by echocardiogram or multiple-gated acquisition left ventricular (MUGA) scan
c. Unstable angina
d. Unstable cardiac arrhythmia
3. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable
4. Patients with any serious concomitant medical condition, which could, in the opinion of the investigator, compromise participation in the study
5. Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent
Recruitment start date
23/01/2006
Recruitment end date
01/04/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3008 AE
Netherlands
Sponsor information
Organisation
Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)
Sponsor details
HOVON Data Center
Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 4391568
hdc@erasmusmc.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Dutch Cancer Society
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary