Condition category
Cancer
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
07/06/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hovon.nl

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

Publication citations

Additional files

Editorial Notes