Study Evaluating Sorafenib Added to Standard Primary Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Less Than 60 Years of Age (SORAML)

February 4, 2016 updated by: Technische Universität Dresden

A Double-blind, Placebo-controlled, Randomized, Multicenter Phase-II Trial to Assess the Efficacy of Sorafenib Added to Standard Primary Therapy in Patients With Newly Diagnosed AML ≤60 Years of Age

Sorafenib is a multikinase inhibitor which is acting on various cellular pathways involved in the genesis of acute myeloid leukemia (AML). Sorafenib is therefore a promising candidate for improvement of chemotherapy results in AML. This clinical trial evaluates the efficacy of sorafenib added to standard chemotherapy for AML in patients between 18 and 60 years of age. Patients are randomised to receive either sorafenib capsules or placebo in addition to their chemotherapy. The placebo and the sorafenib group will be compared regarding event-free survival and other clinical outcomes. An event is either treatment failure or relapse or death. According to the study hypothesis, the sorafenib group will have less events than the placebo group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Phase 2

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
      • Bamberg, Germany, 96049
        • Sozialstiftung Bamberg Klinikum am Bruderwald
      • Bayreuth, Germany, 95445
        • Klinikum Bayreuth
      • Berlin, Germany
        • Charite Campus Benjamin Franklin
      • Bremen, Germany, 28239
        • Ev. Diakonie-Krankenhaus gGmbH Bremen
      • Dresden, Germany, 01307
        • University Hospital Dresden
      • Frankfurt (Oder), Germany, 15236
        • Klinikum Frankfurt (Oder) GmbH
      • Kaiserslautern, Germany, 67655
        • Westpfalz-Klinikum GmbH
      • Rotenburg, Germany, 27356
        • Agaplesion Diakoniekrankenhaus Rotenburg
      • Stuttgart, Germany, 70376
        • Robert-Bosch-Krankenhaus

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 or differential blood count must contain ≥ 20% blasts. In AML FAB M6 ≥ 30% of nonerythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations, the proportion of blasts may be < 20%.
  • Age ≥ 18 and ≤ 60 years
  • Informed consent, personally signed and dated to participate in the study
  • ECOG performance status of 0-1
  • Life expectancy of at least 12 weeks
  • Adequate liver and renal function as assessed by laboratory requirements to be conducted within 7 days prior to Screening

Exclusion criteria:

  • Patients who are not eligible for standard chemotherapy as per discretion of the treating physician
  • Central nervous system manifestation of AML
  • Cardiac disease: heart failure NYHA III or IV; unstable 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 (creatinine clearance < 30 ml/min) (Cockcroft-Gault formula)
  • Patients undergoing renal dialysis
  • Chronic pulmonary disease with relevant hypoxia
  • Known HIV and/or hepatitis C infection
  • Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
  • Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders
  • 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 jeopardize compliance of the protocol
  • Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start of first dose
  • Serious, non-healing wound, ulcer or bone fracture
  • Uncontrolled active infection > Grade 2 NCI-CTC version 3.0
  • Concurrent malignancies other than AML
  • History of organ allograft
  • Allergy to study medication or excipients in study medication

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib
Induction, Consolidation and Maintenance plus Sorafenib 2x 400 mg/d
Drug: sorafenib
Standard AML chemotherapy plus sorafenib 400 mg BID
Other Names:
  • nexavar
Placebo Comparator: Placebo
Induction, Consolidation and Maintenance plus Placebo
Drug: placebo
Standard AML chemotherapy plus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event-free survival
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 36 months
36 months
Rate of complete remissions
Time Frame: 12 weeks
12 weeks
Toxicity
Time Frame: 36 months
36 months

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

Collaborators

Bayer

Investigators

  • Principal Investigator: Gerhard Ehninger, Prof, MD, University Hospital Dresden

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

Helpful Links

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

March 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 4, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 6, 2009

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUD-SORAML-034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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