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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); A randomized phase II study.


- candidate number2075
- NTR NumberNTR655
- ISRCTNISRCTN70542454
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR1-mei-2006
- Secondary IDsHO67 
- Public TitleReduced 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); A randomized phase II study.
- Scientific TitleReduced 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); A randomized phase II study.
- ACRONYMHOVON / SAKK AML - 67
- hypothesisThe hypothesis to be tested is that the outcome in arm 2 is better than in arm 1.
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML)
- Inclusion criteria1. Patients >= 60 years;
2. Patients considered unfit for standard chemotherapy;
3. Patients with a confirmed diagnosis of:
a. AML FAB M0-M2 or M4–M7 (see appendix A);
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;
4. Subjects with secondary AML progressing from antecedent (at least 4 months duration) myelodysplasia are also eligible;
5. 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;
6. 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;
7. Written informed consent.
- Exclusion criteria1. 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 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;
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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-jan-2006
- planned closingdate1-apr-2007
- Target number of participants60
- InterventionsThe 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:
-Ara-C 100 mg/m2/day iv continuous infusion, days 1-5;
-Daunorubicin (DNR) 45 mg/m2/day iv 3h, days 1-2;


The chemotherapy regimen for consolidation is as follows:
-Ara-C 100 mg/m2/day iv continuous infusion, days 1-5;
-Daunorubicin (DNR) 45 mg/m2/day iv 3h, days 1-2;


Patients assigned to the imatinib arm, in addition will receive a daily dose of 600 mg imatinib 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 CR or no PR after cycle I or II.)
- Primary outcomeCR rate.
- Secondary outcome1. 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 / toxicity.
- TimepointsN/A
- Trial web sitehttp://www.hovon.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. B. Löwenberg
- CONTACT for SCIENTIFIC QUERIESProf. Dr. B. Löwenberg
- Sponsor/Initiator HOVON Data Center
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- PublicationsN/A
- Brief summaryStudy phase:
Phase II.

Study objective:
Evaluation of the effect of imatinib on efficacy of reduced intensity induction and consolidation chemotherapy in AML patients >= 60 years considered unfit for standard chemotherapy.

Patient population:
Patients with AML (except FAB M3), RAEB or RAEB-T with an IPSS score of > 1.5.

Study design:
Prospective, multicenter, randomized Duration of treatment: From 4 weeks till 40 weeks dependent on response and whether or not allocated to receive treatment with imatinib.
- Main changes (audit trail)
- RECORD1-mei-2006 - 16-nov-2009


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