Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00003969

Trial Description

start of 1:1-Block title

Title

Phase-II Study Evaluating Midostaurin in Induction, Consolidation and Maintenance Therapy Also After Allogeneic Blood Stem Cell Transplantation in Patients With Newly Diagnosed Acute Myeloid Leukemia Exhibiting a FLT3 Internal Tandem Duplication

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

AMLSG 16-10

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute
Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria.

The primary efficacy object is to evaluate the impact of midostaurin given in combination
with intensive induction, consolidation including allogeneic hematopoietic stem cell
transplantation and single agent maintenance therapy on event-free survival (EFS) in adult
patients with AML exhibiting a FLT3-ITD.

Sample size: 142 patients

The treatment duration of an individual patient is between 18 and 24 months. Duration of the
study for an individual patient including treatment (induction, consolidation [chemotherapy
or allogeneic SCT], maintenance and follow-up period: 48 months

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003969
  •   2012/05/10
  •   2011/11/17
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2011-003168-63 
  •   NCT01477606  (ClinicalTrials.gov)
  •   AMLSG 16-10  (University of Ulm)
  •   2011-003168-63 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Acute Myeloid Leukemia
  •   C92.0 -  Acute myeloid leukaemia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Midostaurin
  •   Drug: Cytarabine
  •   Drug: Daunorubicin
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Event-free Survival; time frame: Two years; To evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Rate of complete remission (CR); time frame: Two months
- Relapse-free survival; time frame: four years
- overall survival; time frame: four years
- Cumulative incidence of relapse; time frame: four years
- cumulative incidence of death in CR; time frame: four years
- Target (FLT3) inhibition by measuring the FLT3 plasma inhibitory activity; time frame: four years; Evaluation of target (FLT3) inhibition by continuous dosing of midostaurin
- Quality of life; time frame: 5 years; Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics initially, in first CR, after one year,3 and 5 years after initial diagnosis.
- Rate of early deaths and hypoplastic deaths (ED/HD); time frame: two months
- Death in CR; time frame: four years
- Toxicities; time frame: between 18 and 24 months; Type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 3.0), timing and relatedness of hematological and non-hematological toxicities observed during the different treatment cycles

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Austria
  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2012/05/31
  •   142
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Patients with suspected diagnosis of AML or related precursor neoplasm, or acute
leukemia of ambiguous lineage (classified according to the World Health Organization
(WHO) 2008 classification)

- Presence of FLT3-ITD assessed in the central AMLSG reference laboratories

- Patients considered eligible for intensive chemotherapy

- WHO performance status of ≤ 2

- Age ≥ 18 years and ≤ 70 years

- No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis (≤
7 days)

- Non-pregnant and non-nursing. Women of childbearing potential (WOCBP) must have a
negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL
within 72 hours prior to registration ("Women of childbearing potential" is defined
as a sexually active mature woman who has not undergone a hysterectomy or who has had
menses at any time in the preceding 24 consecutive months)

- Female patients in the reproductive age and male patients must agree to avoid getting
pregnant or to father a child while on therapy and for 3 month after the last dose of
chemotherapy

- Women of child-bearing potential must either commit to continued abstinence from
heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal
ligation, or partner's vasectomy). Hormonal contraception is an inadequate method of
birth control

- Men must use a latex condom during any sexual contact with women of childbearing
potential, even if they have undergone a successful vasectomy (while on therapy and
for 3 month after the last dose of chemotherapy)

- Signed written informed consent.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

•AML with the following recurrent genetic abnormalities (according to WHO 2008): AML with
t(8;21)(q22;q22); RUNX1-RUNX1T1 AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22);
CBFB-MYH11 AML with t(15;17)(q22;q12); PML-RARA (or variant translocations with other RARA
gene fusions)

- Performance status WHO >2

- Patients with ejection fraction < 50% by MUGA or ECHO scan within 14 days of day 1

- Organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, AST or ALP
>2.5x upper normal serum level, not attributable to AML; heart failure NYHA III/IV;
severe obstructive or restrictive ventilation disorder)

- Uncontrolled infection

- Severe neurological or psychiatric disorder interfering with ability of giving an
informed consent

- Patients with a "currently active" second malignancy other than non-melanoma skin
cancers. Patients are not considered to have a "currently active" malignancy if they
have completed therapy and are considered by their physician to be at less than 30%
risk of relapse within one year

- Known positive for HIV; active HBV, HCV, or Hepatitis A infection

- Bleeding disorder independent of leukemia

- No consent for registration, storage and processing of the individual
disease-characteristics and course as well as information of the family physician
and/or other physicians involved in the treatment of the patient about study
participation.

- No consent for biobanking.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Ulm
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • University Hospital of Ulm
    • Richard F Schlenk, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Sabine Kayser, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   33
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.