Clinical Study of SU 11248 (Sutent) Combined With Standard Chemotherapy in Patients With FLT3 Mutated AML Over 60 Years
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
2 other identifiers
interventional
22
1 country
5
Brief Summary
In this study safety and tolerability of two dose levels of SU 11248 (sutent) with standard chemotherapy in patients with FLT3 mutated AML over 60 years will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 31, 2008
CompletedFirst Posted
Study publicly available on registry
November 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedFebruary 25, 2020
February 1, 2020
4.9 years
October 31, 2008
February 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
April 2011
Secondary Outcomes (2)
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
April 2011
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
April 2011
Interventions
Eligibility Criteria
You may qualify if:
- 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/µl, 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.
You may not qualify if:
- The presence of any of the following will exclude a subject from study enrollment:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Prof. Dr. med. Walter Fiedler
Hamburg, 20246, Germany
PD Dr. med. Jürgen Krauter
Hanover, 30625, Germany
Dr. Katharina Götze
München, 81675, Germany
Prof. Dr. Helmut R. Salih
Tübingen, 72076, Germany
Dr. Richard Schlenk
Ulm, 89081, Germany
Related Publications (1)
Fiedler W, Kayser S, Kebenko M, Janning M, Krauter J, Schittenhelm M, Gotze K, Weber D, Gohring G, Teleanu V, Thol F, Heuser M, Dohner K, Ganser A, Dohner H, Schlenk RF. A phase I/II study of sunitinib and intensive chemotherapy in patients over 60 years of age with acute myeloid leukaemia and activating FLT3 mutations. Br J Haematol. 2015 Jun;169(5):694-700. doi: 10.1111/bjh.13353. Epub 2015 Mar 29.
PMID: 25818407RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Fiedler
Universitätsklinikum Hamburg-Eppendorf
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2008
First Posted
November 3, 2008
Study Start
August 1, 2008
Primary Completion
July 1, 2013
Last Updated
February 25, 2020
Record last verified: 2020-02