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Acute Myeloid Leukemia (AML)Phase 2SORAMLNCT00893373

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 study testing sorafenib in people with Acute Myeloid Leukemia (AML), run by Technische Universität Dresden at 9 sites in Germany.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Acute Myeloid Leukemia (AML)
What is being tested?
sorafenib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
9 sitesGermany
Study dates
Mar 2009to Sep 2014
Phase
Phase 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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Germany9 sites

  • Sozialstiftung Bamberg Klinikum am Bruderwald

    Bamberg, 96049

  • Klinikum Bayreuth

    Bayreuth, 95445

  • Charite Campus Benjamin Franklin

    Berlin

  • Ev. Diakonie-Krankenhaus gGmbH Bremen

    Bremen, 28239

  • University Hospital Dresden

    Dresden, 01307

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), 15236

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, 67655

  • Agaplesion Diakoniekrankenhaus Rotenburg

    Rotenburg (Wümme), 27356

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

Other trials in Germany

About this study

Official title: 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.

Being tested
sorafenib, placebo
Keywords
AML, sorafenib
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.

  • sorafenibDrug

    Also called nexavar

    Standard AML chemotherapy plus sorafenib 400 mg BID

  • placeboDrug

    Standard AML chemotherapy plus placebo

Study groups in NCT00893373
Study groupRoleWhat they receive
SorafenibExperimentalInduction, Consolidation and Maintenance plus Sorafenib 2x 400 mg/d
Receives: Drug: sorafenib
PlaceboPlacebo comparatorInduction, Consolidation and Maintenance plus Placebo
Receives: Drug: placebo

What is being measured

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

  1. Event-free survival

    Measured: 36 months

Secondary outcomes (3)

  1. Overall survival

    Measured: 36 months

  2. Rate of complete remissions

    Measured: 12 weeks

  3. Toxicity

    Measured: 36 months

Timeline

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

  1. First posted6 May 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionNov 2011
  4. Study completionSep 2014

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00893373
Sponsor's protocol ID
TUD-SORAML-034
Acronym
SORAML
Status last verified
Feb 2016
First submitted
4 May 2009
Last updated
5 Feb 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib in people with Acute Myeloid Leukemia (AML), run by Technische Universität Dresden at 9 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 7 inclusion and 17 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 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Event-free survival (time frame: 36 months). 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 NCT00893373, which also lists 3 linked publications.

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 5 Feb 2016.

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