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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 81 AML


News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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1. Overview



Summary

A Phase II multicenter study to assess the tolerability and efficacy of the addition of Bevacizumab to standard induction therapy in AML and high risk MDS above 60 years. A randomized phase II study.


Status

closed



Type of study

Prospective randomized Phase II study


Target number of patients

200


Date of activation

13-Feb-2007


Date closed

18-Aug-2009


Approved by

EudraCTnr.: 2006-001777-19
CKTO: June 27, 2006
MEC: METC VUMC 2006/215, December 7, 2006


Study objectives

Evaluation of the safety and tolerability of Bevacizumab
added to standard induction chemotherapy.
Evaluation of the effect of Bevacizumab on the CR rate.


2. Patient eligibility criteria



Inclusion criteria

Patients > 60 years
Patients eligible for standard chemotherapy
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
Subjects with secondary AML progressing from antecedent (at least 4 months duration) myelodysplasia are also eligible.
SGOT (AST) and SGPT (ALT) <= 1.5 x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
Total serum bilirubin level <= 1.5 x the ULN at the laboratory where the analysis was performed.
Serum creatinine concentration <= 1.5 x the ULN at the laboratory where the analysis was performed.
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.
WHO performance status 2
Written informed consent


Exclusion criteria

Patients previously treated for AML (any antileukemic therapy including investigational agents)
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'
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.
Uncontrolled hypertension
Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance
Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study.
Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
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
Serious, non-healing wound, ulcer, or bone fracture
Patients with bleeding diathesis or coagulopathy (unless related to AML)
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.


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Patient's initials or code
Patient's hospital record number (optional)
Sex
Date of birth
Eligibility criteria


4. Participating parties



Principal investigator

G.J. Ossenkoppele (g.ossenkoppele@vumc.nl)


Coordinating investigator(s)

B. Löwenberg (b.lowenberg@erasmusmc.nl)


Statistician(s)

Y. van Norden (y.vannorden@erasmusmc.nl)


Trial manager

R. Hollestein (r.hollestein@eramusmc.nl)


Central data management

R. Hollestein (r.hollestein@eramusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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