The hypothesis to be tested is that the outcome in arm 2 is better than in arm 1.
ID
Bron
Verkorte titel
Aandoening
AML
Ondersteuning
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
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
CR rate.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The hypothesis to be tested is that the outcome in arm 2 is better than in arm 1.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.)
Publiek
P.O. Box 5201
B. Löwenberg
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391598
b.lowenberg@erasmusmc.nl
Wetenschappelijk
P.O. Box 5201
B. Löwenberg
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391598
b.lowenberg@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL599 |
NTR-old | NTR655 |
Ander register | : HO67 |
ISRCTN | ISRCTN70542454 |