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CompletedNCT00893373SORAMLUpdated Feb 5, 2016

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

A Phase 2 interventional study of sorafenib and placebo in Acute Myeloid Leukemia (AML), sponsored by Technische Universität Dresden. Completed at 9 sites in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-02-05.

Sponsored by Technische Universität Dresden · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
276
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Acute Myeloid Leukemia (AML)

Keywords

  • AML
  • sorafenib
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In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 276 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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 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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
276 participants (actual)

Study arms

  • Experimental
    Sorafenib

    Induction, Consolidation and Maintenance plus Sorafenib 2x 400 mg/d

    Drug: sorafenib

  • Placebo comparator
    Placebo

    Induction, Consolidation and Maintenance plus Placebo

    Drug: placebo

Interventions

  • Drugsorafenib

    Standard AML chemotherapy plus sorafenib 400 mg BID

    Also known as: nexavar

  • Drugplacebo

    Standard AML chemotherapy plus placebo

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What researchers measure

Primary outcomes

  1. Event-free survival

    Time frame: 36 months

Secondary outcomes

  1. Overall survival

    Time frame: 36 months

  2. Rate of complete remissions

    Time frame: 12 weeks

  3. Toxicity

    Time frame: 36 months

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Study locations

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

Publications

  • Kunadt D, Stasik S, Metzeler KH, Rollig C, Schliemann C, Greif PA, Spiekermann K, Rothenberg-Thurley M, Krug U, Braess J, Kramer A, Hochhaus A, Scholl S, Hilgendorf I, Brummendorf TH, Jost E, Steffen B, Bug G, Einsele H, Gorlich D, Sauerland C, Schafer-Eckart K, Krause SW, Hanel M, Hanoun M, Kaufmann M, Wormann B, Kramer M, Sockel K, Egger-Heidrich K, Herold T, Ehninger G, Burchert A, Platzbecker U, Berdel WE, Muller-Tidow C, Hiddemann W, Serve H, Stelljes M, Baldus CD, Neubauer A, Schetelig J, Thiede C, Bornhauser M, Middeke JM, Stolzel F; A. M. L. Cooperative Group (AMLCG), Study Alliance Leukemia (SAL). Impact of IDH1 and IDH2 mutational subgroups in AML patients after allogeneic stem cell transplantation. J Hematol Oncol. 2022 Sep 5;15(1):126. doi: 10.1186/s13045-022-01339-8. PubMed 36064577 ↗
  • Rollig C, Serve H, Huttmann A, Noppeney R, Muller-Tidow C, Krug U, Baldus CD, Brandts CH, Kunzmann V, Einsele H, Kramer A, Schafer-Eckart K, Neubauer A, Burchert A, Giagounidis A, Krause SW, Mackensen A, Aulitzky W, Herbst R, Hanel M, Kiani A, Frickhofen N, Kullmer J, Kaiser U, Link H, Geer T, Reichle A, Junghanss C, Repp R, Heits F, Durk H, Hase J, Klut IM, Illmer T, Bornhauser M, Schaich M, Parmentier S, Gorner M, Thiede C, von Bonin M, Schetelig J, Kramer M, Berdel WE, Ehninger G; Study Alliance Leukaemia. Addition of sorafenib versus placebo to standard therapy in patients aged 60 years or younger with newly diagnosed acute myeloid leukaemia (SORAML): a multicentre, phase 2, randomised controlled trial. Lancet Oncol. 2015 Dec;16(16):1691-9. doi: 10.1016/S1470-2045(15)00362-9. Epub 2015 Nov 6. PubMed 26549589 ↗
  • Herold T, Metzeler KH, Vosberg S, Hartmann L, Rollig C, Stolzel F, Schneider S, Hubmann M, Zellmeier E, Ksienzyk B, Jurinovic V, Pasalic Z, Kakadia PM, Dufour A, Graf A, Krebs S, Blum H, Sauerland MC, Buchner T, Berdel WE, Woermann BJ, Bornhauser M, Ehninger G, Mansmann U, Hiddemann W, Bohlander SK, Spiekermann K, Greif PA. Isolated trisomy 13 defines a homogeneous AML subgroup with high frequency of mutations in spliceosome genes and poor prognosis. Blood. 2014 Aug 21;124(8):1304-11. doi: 10.1182/blood-2013-12-540716. Epub 2014 Jun 12. PubMed 24923295 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00893373
Lead sponsor
Technische Universität Dresden
Collaborators
Bayer
Responsible party
Sponsor
First posted
May 6, 2009
Start date
Mar 2009
Primary completion
Nov 2011
Completion
Sep 2014
Last update
Feb 5, 2016

Study contacts

Gerhard Ehninger, Prof, MD
principal investigator · University Hospital Dresden

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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