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Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00373373
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : August 19, 2009
Information provided by:
University Hospital Muenster

Brief Summary:
The primary purpose of the study is to determine, whether the addition of Sorafenib to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Sorafenib Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized, Multi-center Phase II Trial to Assess the Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML
Study Start Date : September 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Placebo Comparator: A
Chemotherapy + Placebo
Drug: Placebo
Chemotherapy + Placebo

Active Comparator: B
Chemotherapy + Sorafenib
Drug: Sorafenib
2 x 400 mg/d
Other Name: Nexavar

Primary Outcome Measures :
  1. Median Event Free Survival of all AML patients

Secondary Outcome Measures :
  1. Median Event Free Survival of AML patients with Flt3-ITD mutations
  2. Median Event Free Survival of the patients in each of the four strata (Flt3 Non-ITD/NPM1 WT, Flt3 Non-ITD/NPM1 mut, Flt3 ITD/NPM1 WT, Flt3 ITD/NPM1 mut)
  3. Median Overall Survival of AML patients with Flt3-ITD mutations
  4. Median Overall Survival of all AML patients
  5. Rate of Complete Remission in all AML patients
  6. Rate of Molecular Remission in all AML patients
  7. Toxicity
  8. Evidence of Minimal Residual Disease in all AML patients
  9. Development of Biomarkers indicating the course of disease

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   61 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with newly diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML)
  • Bone marrow aspirate or biopsy must contain >= 20% blasts of all nucleated cells, with the exception of AML FAB M6, where >= 30% of non-erythroid cells must be leukemic blasts
  • Age >= 61 years
  • Informed consent, personally signed and dated to participate in the study
  • Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the Sorafenib treatment and for at least 3 months after the last administration of Sorafenib

Exclusion Criteria:

  • Central nervous system manifestation of AML
  • Cardiac Disease: Heart failure NYHA III° or IV°; active coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
  • Chronically impaired renal function (creatinin clearance < 30 ml/min)
  • Chronic pulmonary disease with relevant hypoxia
  • Inadequate liver function (ALT and AST >= 2.5 x ULN)
  • Total bilirubin >= 1.5 x ULN
  • Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg
  • Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
  • Uncontrolled active infection
  • Concurrent malignancies other than AML
  • Previous treatment of AML except hydroxyurea and up to 2 days <= 100 mg/m²/d cytarabine
  • Known HIV and/or hepatitis C infection
  • Evidence or history of CNS disease, including primary or metastatic brain tumors, seizure disorders
  • Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry
  • Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
  • History of organ allograft
  • Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg
  • Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose
  • Serious, non-healing wound, ulcer or bone fracture
  • Allergy to study medication or excipients in study medication
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  • Patients who are not eligible for standard chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00373373

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Charité Campus Benjamin Franklin, Med. Klinik III
Berlin, Germany, 12203
Klinikum Chemnitz GmbH, Klinik für Innere Medizin III
Chemnitz, Germany, 09113
Universitätsklinikum Carl Gustav Carus der TU Dresden, Medizinische Klinik I
Dresden, Germany, 01307
St. Johannes Hospital, Medizinische Klinik II
Duisburg, Germany, 47166
Universitätsklinikum Essen, Zentrum für Innere Medizin, Medizinische Klinik und Poliklinik für Hämatologie
Essen, Germany, 45147
Klinikum der J. W. Goethe-Universität Frankfurt am Main, Medizinische Klinik II
Frankfurt / Main, Germany, 60590
Allgemeines Krankenhaus St. Georg, Hämatologische Abteilung
Hamburg, Germany, 20099
Universitätsklinikum Heidelberg, Med. Klinik V
Heidelberg, Germany, D-69120
Klinikum der Universität zu Köln, Klinik I für Innere Medizin
Köln, Germany, 50937
Klinikum der Johannes Gutenberg Universität, 3. Medizinische Klinik und Poliklinik
Mainz, Germany, 55101
Philipps Universität, Abteilung für Hämatologie, Onkologie und Immunologie
Marburg, Germany, 35043
Klinik für Hämatologie und Onkologie Klinikum Minden
Minden, Germany, 32423
TU München, Medizinische Klinik III
München, Germany, 81675
Universitätsklinikum Münster, Medizinische Klinik A
Münster, Germany, 48149
Klinikum Nürnberg, 5. Medizinische Klinik Einheit für Knochenmarktransplantation
Nürnberg, Germany, 90419
Universität Regensburg, Abteilung für Hämatologie und Internistische Onkologie
Regensburg, Germany, 93042
Robert-Bosch Krankenhaus Stuttgart
Stuttgart, Germany, 70376
Julius-Maximilians-Universität Würzburg, Medizinische Klinik und Poliklinik II
Würzburg, Germany, 97979
Sponsors and Collaborators
University Hospital Muenster
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Principal Investigator: Hubert Serve, MD Klinikum der J.W. Goethe Universität Frankfurt, Med. Klinik II

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Responsible Party: Hubert Serve (Principal Investigator), Klinikum der J.W. Goethe Universität Frankfurt, Med. Klinik II Identifier: NCT00373373     History of Changes
Other Study ID Numbers: KKS/INNERE_A/AML2006
EudraCT Number: 2005-005966-35
Sorafenib in AML
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: August 19, 2009
Last Verified: August 2009
Keywords provided by University Hospital Muenster:
Acute Myeloid Leukemia
Kinase Inhibitor
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action