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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00893373
First received: May 4, 2009
Last updated: February 2, 2012
Last verified: February 2012

May 4, 2009
February 2, 2012
March 2009
November 2011   (final data collection date for primary outcome measure)
Event-free survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00893373 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Rate of complete remissions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Evaluating Sorafenib Added to Standard Primary Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Less Than 60 Years of Age
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Myeloid Leukemia (AML)
  • Drug: sorafenib
    Standard AML chemotherapy plus sorafenib 400 mg BID
  • Drug: placebo
    Standard AML chemotherapy plus placebo
  • Experimental: Sorafenib
    Induction, Consolidation and Maintenance plus Sorafenib 2x 400 mg/d
    Intervention: Drug: sorafenib
  • Placebo Comparator: Placebo
    Induction, Consolidation and Maintenance plus Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
276
Not Provided
November 2011   (final data collection date for primary outcome measure)

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 the following laboratory requirements to be conducted within 7 days prior to screening:
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00893373
TUD-SORAML-034
Yes
Technische Universität Dresden
Technische Universität Dresden
Bayer
Principal Investigator: Gerhard Ehninger, Prof, MD University Hospital Dresden
Technische Universität Dresden
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP