AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 1/2NCT00783653

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

A Phase 1/2 study testing Sunitinib in people with Acute Myeloid Leukemia, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Sunitinib
How many people
22 participants
Where
5 sitesGermany
Study dates
Aug 2008to Jul 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Prof. Dr. med. Walter Fiedler

    Hamburg, 20246

  • PD Dr. med. Jürgen Krauter

    Hanover, 30625

  • Dr. Katharina Götze

    München, 81675

  • Prof. Dr. Helmut R. Salih

    Tübingen, 72076

  • Dr. Richard Schlenk

    Ulm, 89081

Other trials in Germany

About this study

Official 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

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.

Being tested
Sunitinib
Keywords
AML, FLT3, acute myeloid leukemia, FLT 3 inhibitor, FLT3 mutated AML
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SunitinibDrug

    Also called SU11248, Sutent

    25 mg or 37,5 mg daily dose until DLT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: April 2011

Secondary outcomes (2)

  1. 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

    Measured: April 2011

  2. 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

    Measured: April 2011

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00783653
Sponsor's protocol ID
AMLSG 10/07
Other IDs
AMLSG-SU11248
Status last verified
Feb 2020
First submitted
31 Oct 2008
Last updated
25 Feb 2020
Results posted
No
Data monitoring committee
No

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.

    PubMed 25818407

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sunitinib in people with Acute Myeloid Leukemia, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00783653, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in