The hypothesis to be tested is that arm B is tolerable and that the outcome in arm B is better than in arm A.
ID
Bron
Verkorte titel
Aandoening
Acute Myeloid leukemia (AML), RAEB(-t)
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
Koningin Wilhelmina Fonds (KWF)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Incidence of DLT and the effect of bevacizumab on the CR-rate
Achtergrond van het onderzoek
Study phase: Phase II
Study objective: Evaluation of the safety and tolerability of Bevacizumab added to standard induction chemotherapy. Evaluation of the effect of Bevacizumab on the CR rate
Patient population: Patients with AML (except FAB M3), RAEB or RAEB-t with IPSS ¡Ý 1.5, previously untreated, age > 60 yrs.
Study design: Prospective, multicenter, open-label, with randomization between standard induction chemotherapy with or without Bevacizumab.The initial Bevacizumab dose is 5 mg/kg i.v. on day 1+15 of each cycle. Decisions regarding dose escalation to 10 mg/kg, continuation with dose level 5 mg/kg, or stopping, are based on the incidence of DLT (dose limiting toxicity: death within 30 days of start cycle I and before start cycle II)Duration of treatment: Expected duration of 2 cycles of induction chemotherapy with of without Bevacizumab including evaluation is about 3 months.
Doel van het onderzoek
The hypothesis to be tested is that arm B is tolerable and that the outcome in arm B is better than in arm A.
Onderzoeksproduct en/of interventie
Patients will be randomized on entry between:
Arm A: Cycle I: daunorubicine/cytarabine-arabinoside. Cycle II: intermediate dose cytarabine-arabinoside.
Or Arm B: Cycle I: daunorubicine/cytarabine-arabinoside and 2 doses of bevacizumab 5 or 10 mg/kg. Cycle II: intermediate dose cytarabine-arabinoside and 2 doses of bevacizumab 5 or 10 mg/kg
Publiek
Postbus 7057
G.J. Ossenkoppele
Amsterdam 1007 NL
The Netherlands
+31 20 4442604
g.ossenkoppele@vumc.nl
Wetenschappelijk
Postbus 7057
G.J. Ossenkoppele
Amsterdam 1007 NL
The Netherlands
+31 20 4442604
g.ossenkoppele@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients > 60 years.
2. Patients eligible for standard chemotherapy.
3. Patients with a confirmed diagnosis of AML FAB M0-M2 or M4-M7 or 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. SGOT (AST) and SGPT (ALT) <= 1.5 x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
6. Total serum bilirubin level <= 1.5 x the ULN at the laboratory where the analysis was performed.
7. Serum creatinine concentration <= 1.5 x the ULN at the laboratory where the analysis was performed.
8. Proteinuria at baseline: Urine dipstick of proteinuria <2+. Patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate <= 1 g of protein/24 hr.
9. WHO performance status <= 2
10. 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. Past or current history (within the last 2 years prior to randomization) of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
3. Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (<= 6 months prior to randomization), myocardial infarction (<= 6 months prior to randomization), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, reduced left ventricular ejection fraction of < 50% as evaluated by echocardiogram or MUGA scan.
4. Uncontrolled hypertension
5. Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance
6. Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study.
7. Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study
9. Serious, non-healing wound, ulcer, or bone fracture
10. Patients with bleeding diathesis or coagulopathy (unless related to AML)
11. Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of bevacizumab formulation; or to any other study drugs.
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 | NL888 |
NTR-old | NTR904 |
Ander register | : HO81 |
ISRCTN | ISRCTN18332222 |