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A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Last updated on August 23, 2019

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Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Patients with AML or RAEB 2 High Risk MDS who are newly diagnosed according to the WHO
2008 Classification and previously untreated.

- Patients with AML (arising from an antecedent hematologic disease [AHD]) or MDS who
may have had one prior regimen with commercially available agents for the treatment of
their prior hematologic disease. The patients may not have had a prior therapy for
their AML.

- AML patients include de novo AML, AML evolving from MDS or other AHD and AML after
previous cytotoxic therapy or radiation (secondary AML)

- For a diagnosis of AML, a bone marrow blast count of 20% or more is required.

- For a diagnosis of high-risk Myelodysplastic Syndrome RAEB 2 the patient must have
10-19% bone marrow blasts

- Adequate Organ Function

- ECOG Performance Status 0, 1, or 2

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic
translocation.

- Patients with known active uncontrolled central nervous system (CNS) leukemia.

NCT01546038
Pfizer
Completed
A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

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[email protected]

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1-800-718-1021

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