Clinical Study of SU 11248 (Sutent) Combined With Standard Chemotherapy in Patients With FLT3 Mutated AML Over 60 Years

NCT ID: NCT00783653

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Sunitinib

25 mg or 37,5 mg daily dose until DLT

Intervention Type: DRUG

Other Intervention Names

SU11248, Sutent

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Fiedler

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Prof. Dr. med. Walter Fiedler

Hamburg, , Germany

PD Dr. med. Jürgen Krauter

Hanover, , Germany

Dr. Katharina Götze

München, , Germany

Prof. Dr. Helmut R. Salih

Tübingen, , Germany

Dr. Richard Schlenk

Ulm, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 25818407 (View on PubMed)

Other Identifiers

AMLSG-SU11248

Identifier Type: -

Identifier Source: secondary_id

AMLSG 10/07

Identifier Type: -

Identifier Source: org_study_id