Clinical trial · Interventional
Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
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])
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tipifarnib;Zarnestra; R115777 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHarousseau JL, Martinelli G, Jedrzejczak WW, Brandwein JM, Bordessoule D, Masszi T, Ossenkoppele GJ, Alexeeva JA, Beutel G, Maertens J, Vidriales MB, Dombret H, Thomas X, Burnett AK, Robak T, Khuageva NK, Golenkov AK, Tothova E, Mollgard L, Park YC, Bessems A, De Porre P, Howes AJ; FIGHT-AML-301 Investigators. A randomized phase 3 study of tipifarnib compared with best supportive care, including hydroxyurea, in the treatment of newly diagnosed acute myeloid leukemia in patients 70 years or older. Blood. 2009 Aug 6;114(6):1166-73. doi: 10.1182/blood-2009-01-198093. Epub 2009 May 21. PMID 19470696