Kompetenznetz "Akute und chronische Leukämien"

Kompetenznetz "Akute und chronische Leukämien"
SHORTPROTOCOL
AMLSG 10-07
Public Title
SU11248 Combined With Standard Chemotherapy in Patients With FLT3 Mutated AML
Scientific Title
Phase I/II Clinical Study of SU11248 (Sutent) Combined With Standard Chemotherapy
With Cytosine Arabinoside and Daunorubicin in Patients With FLT3 Mutated AML Over
60 Years of Age
Short Title
AMLSG 10-07
Id KN/ELN
LN_AMLSGU_2008_291
Trialgoup
AMLSG Ulm
Type of Trial
single-group, open-label
Phase
Phase I/II
Disease
Acute myeloid leukemia( AML) AML all subtypes without FAB M3
Stage of Disease
de novo/non-treated - Therapy concepts for specific genotypes - >= 60 years
Aim
-
Definition of a recommended Phase III dose and determination CTC version 3.0
grade 3-5 non-hematological toxicities of SU11248 in combination with standard
induction and consolidation chemotherapy
-
Overall safety profile of SU11248 characterized by type, frequency, severity (graded
using NCI CTCAE Version 3.0), timing and relatedness of adverse events (AEs) and
laboratory
-
Objective tumor response, as defined using the revised recommendations of the
International Working Group for diagnosis, standardization of response criteria in
Acute Myeloid Leukemia for AML
-
Patients with primary or secondary acute myeloid leukemia (any FAB type, except
M3).
-
No prior systemic chemotherapy for AML except hydroxyurea. Cytoreductive therapy
with hydroxyurea is recommended if WBC is > 50.000/ìl, but should cease at least
one day prior to starting study medication
-
Patient age equal or of greater than 60 years
-
Patients must have FLT3 mutated AML, either ITD or kinase domain mutations
-
ECOG Performance score 3 or less (Karnofsky Performance Score >40%).
-
Life expectancy more than four weeks.
-
Adequate hepatic and renal function, as defined by serum transaminases <2.5x ULN,
bilirubin <1.5x ULN. Creatinine <1.5x ULN.
-
Patients must provide written informed consent to participate in the trial.
-
Normal heart function on cardiac ultrasound
-
Prothrombin time (PT) and partial thromboplastin time (PTT) <=1.5 x ULN
-
Serum albumin >=3.0 g/dl
-
Serum amylase and lipase <=1.0 x ULN
-
Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.
-
Treatment with any investigational agent within four weeks.
-
Known HIV infection
-
Presence of any medical or psychiatric condition which may limit full compliance with
the study, including but not limited to:
-
Presence of CNS leukaemia
-
Unresolved toxicity from previous anti-cancer therapy or incomplete recovery from
surgery.
Inclusion Criteria
Exclusion Criteria
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Kompetenznetz "Akute und chronische Leukämien"
SHORTPROTOCOL
AMLSG 10-07
-
Any of the following within the 12 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, pulmonary embolism, deep vein thrombosis, or other
thromboembolic event.
-
Current treatment with therapeutic doses of anticoagulant (low dose Coumadin up to
2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
-
Hypertension that cannot be controlled by medications (>150/100 mmHg despite
optimal medical therapy).
-
Pre existing thyroid abnormality of thyroid function that cannot be maintained in the
normal range with medication.
-
Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, atrial fibrillation of any
Grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for
females.
-
Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results, and in the
judgment of the investigator would make the patient inappropriate for entry into this
study.
Age
>= 60 years
Status
No longer recruiting
start of Recruitment
30.11.2008
Leader
Fiedler, Prof. Dr. med., Walter
Universitätsklinikum Hamburg Eppendorf
Medizinische Klinik II
Martinistr. 52
20246 Hamburg
Tel: +49 (0)40 43803-3980 / -3919 / -2915
Fax: +49 (0)40 42803-2849
Email: fiedler@uke-hamburg.de
Scientific Contact (WHO)
Fiedler, Prof. Dr. med., Walter
Universitätsklinikum Hamburg Eppendorf
Medizinische Klinik II
Martinistr. 52
20246 Hamburg
Tel: +49 (0)40 43803-3980 / -3919 / -2915
Fax: +49 (0)40 42803-2849
Email: fiedler@uke-hamburg.de
Contact Person
Study Centre
Groner, Silja
Tel: +49 (0)731 500-45911
Fax: +49 (0)731 500-45915
Email: silja.groner@uniklinik-ulm.de
Centre of Trial
Universitätsklinikum Hamburg-Eppendorf
Diagnostics
Cytogenetics
Labor für Zytogenetische und Molekulargenetische Diagnostik, Klinik für Innere Med. III,
Universitätsklinikum Ulm
Labor für Leukämieforschung der Medizinischen Hochschule Hannover
Other Registers
ClinicalTrials.govNCT00783653
© Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.kompetenznetz-leukaemie.de | www.studienregister-online.de
Stand: 16.01.2017; page 2 of 3
Kompetenznetz "Akute und chronische Leukämien"
SHORTPROTOCOL
AMLSG 10-07
Therapy
Dose-escalation will be performed based on the safety and tolerability. Cohorts of 3
patients (to be expanded up to 6 if 1 DLT is observed among the 3 patients) will be
sequentially allotted to progressively higher dose levels of SU11248 on the basis of the
presence and severity of SU11248 related toxicity encountered in the first cycle. The
AMLSG Clinical Trials Office will assign the dose level at the time of patient confirmation
of enrollment. In the case that continuous dosing is not possible two lower dose levels –1
and –2 will be instituted. The SU11248 dose will be 25 mg for dose levels 1, -1, –2 and
37.5 mg for dose level 2. Dose Level Daily dose(mg) Treatment duration 1 25
continuously 2 37.5 continuously -1 25 Day 1-7 of a cycle, continuously after recovery of
blood counts -2 25 Day 8-15 of a cycle, continuously after recovery of blood counts
© Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.kompetenznetz-leukaemie.de | www.studienregister-online.de
Stand: 16.01.2017; page 3 of 3