No registrations found.
ID
Source
Brief title
Health condition
AML
Sponsors and support
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Intervention
Outcome measures
Primary outcome
CR rate.
Secondary outcome
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 / toxicity.
Background summary
Study 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.
Study objective
The hypothesis to be tested is that the outcome in arm 2 is better than in arm 1.
Study design
N/A
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:
-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.)
P.O. Box 5201
B. Löwenberg
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391598
b.lowenberg@erasmusmc.nl
P.O. Box 5201
B. Löwenberg
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391598
b.lowenberg@erasmusmc.nl
Inclusion criteria
1. 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 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 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL599 |
NTR-old | NTR655 |
Other | : HO67 |
ISRCTN | ISRCTN70542454 |