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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


Phase 2
18 Years
60 Years
Not Enrolling
Both
Acute Myeloid Leukemia (AML)

Thank you

Trial Information

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

Inclusion 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:

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Outcome Time Frame:

36 months

Safety Issue:

Yes

Principal Investigator

Gerhard Ehninger, Prof, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Dresden

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

TUD-SORAML-034

NCT ID:

NCT00893373

Start Date:

March 2009

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia (AML)
  • AML
  • sorafenib
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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