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

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 is currently recruiting participants.

Verified by University Hospital Carl Gustav Carus, May 2009

First Received: May 4, 2009 No Changes Posted

Sponsors and Collaborators:	University Hospital Carl Gustav Carus Bayer
Information provided by:	University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier:	NCT00893373

Purpose

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.

Condition	Intervention	Phase
Acute Myeloid Leukemia (AML)	Drug: sorafenib Drug: placebo	Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by University Hospital Carl Gustav Carus:

Primary Outcome Measures:

Event-free survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	276
Study Start Date:	March 2009
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sorafenib: Experimental Induction, Consolidation and Maintenance plus Sorafenib 2x 400 mg/d	Drug: sorafenib sorafenib 400 mg BID
Placebo: Placebo Comparator Induction, Consolidation and Maintenance plus Placebo	Drug: placebo

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893373

Contacts

Contact: Christoph Rollig, MD	+49 351 458 - 0 ext 3775	christoph.roellig@uniklinikum-dresden.de
Contact: Malte von Bonin, MD	+49 351 458 - 0 ext 8110	malte.bonin@uniklinikum-dresden.de

Locations

Germany
University Hospital Dresden	Recruiting
Dresden, Germany, 01307

Sponsors and Collaborators

University Hospital Carl Gustav Carus

Bayer

Investigators

Principal Investigator:

Gerhard Ehninger, Prof, MD

University Hospital Dresden

More Information

No publications provided

Responsible Party:	Technical University Dresden, University Hospital Carl Gustav Carus, MK1 ( Prof. Dr. Gerhard Ehninger )
Study ID Numbers:	TUD-SORAML-034
Study First Received:	May 4, 2009
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00893373 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Carl Gustav Carus:

AML
sorafenib

Study placed in the following topic categories:

Leukemia
Acute Myelocytic Leukemia
Leukemia, Myeloid

Leukemia, Myeloid, Acute
Protein Kinase Inhibitors
Sorafenib

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Protein Kinase Inhibitors
Sorafenib
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009