Acute Myeloid Leukemia Clinical Trial
Official title:
A Randomized Study of Tipifarnib Versus Best Supportive Care (Including Hydroxyurea) in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) in Subjects 70 Years or Older (Farnesyl Transferase Inhibition Global Human Trials AML 301 [F.I.G.H.T. AML 301])
The purpose of this study is to determine the effectiveness of tipifarnib in patients aged 70 or more with acute myeloid leukemia. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make leukemia cells grow.
Status | Completed |
Enrollment | 457 |
Est. completion date | October 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 70 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Newly diagnosed or re-lapsing AML - Patient not medically fit for combination induction chemotherapy - Pathologic confirmation of AML (= or > 20% bone marrow leukemic blasts) - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. Exclusion Criteria: - Previous cytotoxic or biologic treatment for AML - Acute promyelocytic leukemia (APL) - Central nervous system leukemia - Uncontrolled systemic infection - Uncompensated disseminated intravascular coagulation - Symptomatic neuropathy of grade 2 or worse - Known allergy to imidazole drugs. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | |||
Secondary | Compare patients treated with tipifarnib and patients treated with best supportive care: progression-free survival; complete remission rate; rate of morphologic leukemia-free state; one-year survival estimate and health resources utilization. |
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