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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON 72 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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News


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1. Overview



Summary

Dose escalation trial of bortezomib with standard remission-induction chemotherapy in patients with relapsed acute myelocytic leukemia (AML) or refractory anemia with excess of blasts (RAEB, RAEB-t) with IPSS score >= 1.5


Status

closed



Type of study

Prospective Phase I/II Study


Target number of patients

30


Date of activation

28-Dec-2005


Date closed

15-Nov-2006


Approved by

CKTO: CKTO 2005-11, September 8, 2005
MEC: METC Erasmus MC, November 8, 2005


Study objectives

Evaluation of the effect of escalated dose of bortezomib in re-induction therapy.
Evaluation of bortezomib in combination with daunorubicin and cytarabine


2. Patient eligibility criteria



Inclusion criteria

Age 18-60 years, inclusive.
Subjects with a cytopathologically confirmed diagnosis of AML (M0-M7, FAB classification except FAB M3 or t(15;17)), or with refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >= 1.5 or patients with therapy-related AML/RAEB/RAEB-t. Also patients with biphenotypic leukemia may be included.
Patients who have experienced a previous CR of at least 3 months duration and with a treatment free interval since last treatment of at least 3 months
WHO performance status <= 2 (see appendix E)
Written informed consent


Exclusion criteria

Patients with primary refractory disease or who have relapsed within 3 months after obtaining a first CR
Anti-leukemia treatment within the last 3 months
Impaired hepatic or renal function as defined by:
a. ALT and/or AST > 3 x Upper Limit of Normal (ULN), or
b. Bilirubin > 3 x ULN, or
c. Serum creatinin > 3 x ULN (after adequate hydration), or (unless these are most likely caused by AML organ infiltration)
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etcetera), or
Cardiac dysfunction as defined by:
a. Myocardial infarction within the last 6 months of study entry, or
b. Reduced left ventricular function with an ejection fraction < 50% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable), or
c. Unstable angina, or
d. Unstable cardiac arrhythmias
Pregnant or lactating females
Unwillingness or not capable to use effective means of birth control


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
Sex
Date of birth
Date of diagnosis of AML or RAEB or RAEB-t
Date of relapse
Eligibility criteria


4. Participating parties



Principal investigator

P. Sonneveld (p.sonneveld@erasmusmc.nl)


Coordinating investigator(s)

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


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)


Trial manager

S. Ramnarain (s.ramnarain@erasmusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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