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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), refractory anemia with excess blasts in transformation (RAEB-T): a randomized phase II study |
| ISRCTN | ISRCTN70542454 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | HOVON / SAKK AML - 67 |
| Serial number at source | HO67 |
| Study hypothesis | The hypothesis to be tested is that the outcome in arm 2 is better than in arm 1. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomized phase II study |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Acute myeloid leukemia (AML) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 23/01/2006 |
| Anticipated end date | 01/04/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 60 |
| Interventions |
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.) |
| Primary outcome measure(s) | Complete remission (CR) rate |
| Secondary outcome measure(s) |
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. |
| Sources of funding | Dutch Cancer Society |
| Trial website | http://www.hovon.nl |
| Publications | |
| Contact name | Prof B. Löwenberg |
| Address |
Erasmus Medical Center Daniel den Hoed Cancer Center Department of Hematology P.O. Box 5201 |
| City/town | Rotterdam |
| Zip/Postcode | 3008 AE |
| Country | Netherlands |
| Tel | +31 (0)10 4391598 |
| Fax | +31 (0)10 4391004 |
| b.lowenberg@erasmusmc.nl | |
| Sponsor | Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) |
| Address |
HOVON Data Center Erasmus Medical Center Daniel den Hoed Cancer Center P.O. Box 5201 |
| City/town | Rotterdam |
| Zip/Postcode | 3008 AE |
| Country | Netherlands |
| Tel | +31 (0)10 4391568 |
| Fax | +31 (0)10 4391028 |
| hdc@erasmusmc.nl | |
| Date applied | 07/06/2006 |
| Last edited | 07/06/2006 |
| Date ISRCTN assigned | 07/06/2006 |
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