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Clinical picture: AML (Acute Myeloide Leukemia)
Trial: HOVON 72 AML
News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms
News
No news
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
Study details
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)
