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), refractory anemia with excess blasts in transformation (RAEB-T): a randomized phase II study

ISRCTN	ISRCTN70542454
DOI	https://doi.org/10.1186/ISRCTN70542454
Secondary identifying numbers	HO67

Submission date: 07/06/2006
Registration date: 07/06/2006
Last edited: 07/06/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof B. Löwenberg
Scientific

Erasmus Medical Center
Daniel den Hoed Cancer Center
Department of Hematology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Phone	+31 (0)10 4391598
Email	b.lowenberg@erasmusmc.nl

Study information

Study design	Randomized phase II study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	HOVON / SAKK AML - 67
Study objectives	The hypothesis to be tested is that the outcome in arm 2 is better than in arm 1.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Imatinib mesylate
Primary outcome measure	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 study start date	23/01/2006
Completion date	01/04/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	60
Key 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
Key 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
Date of first enrolment	23/01/2006
Date of final enrolment	01/04/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Center

Rotterdam
3008 AE
Netherlands

Sponsor information

Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)
Research organisation

HOVON Data Center
Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Phone	+31 (0)10 4391568
Email	hdc@erasmusmc.nl
"ROR"	https://ror.org/056kpdx27

Funders

Funder type

Research organisation

Dutch Cancer Society

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan