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

February 22, 2020 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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.

Study Overview

Status

Completed

Conditions

Acute Myeloid Leukemia

Intervention / Treatment

Drug: Sunitinib

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Hamburg, Germany, 20246
    - Prof. Dr. med. Walter Fiedler
  - Hannover, Germany, 30625
    - PD Dr. med. Jürgen Krauter
  - München, Germany, 81675
    - Dr. Katharina Götze
  - Tübingen, Germany, 72076
    - Prof. Dr. Helmut R. Salih
  - Ulm, Germany, 89081
    - Dr. Richard Schlenk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Time Frame: April 2011	April 2011

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Time Frame: April 2011	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 Time Frame: April 2011	April 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

Principal Investigator: Walter Fiedler, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

October 31, 2008

First Submitted That Met QC Criteria