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A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure

Phase 3
18 Years
Open (Enrolling)
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts in Transformation

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Trial Information

A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure


I. Compare disease-free survival in patients with acute myeloid leukemia in second or
subsequent complete remission or in first complete remission treated with tipifarnib as
maintenance therapy vs observation alone.


I. Compare overall survival in patients treated with these regimens. II. Determine long-term
safety and toxicity of tipifarnib in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
remission status (first complete remission [CR] vs > first CR) and prior treatment for the
most current remission (consolidation therapy vs no therapy). Patients are randomized to 1
of 2 treatment arms.

ARM I: Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo observation only.

Patients are followed for up to 5 years.

Inclusion Criteria:

- Morphologically confirmed acute myeloid leukemia (AML) of 1 of the following types:

- Acute myeloblastic leukemia (M0, M1, or M2)

- Acute myelomonocytic leukemia (M4)

- Acute monocytic leukemia (M5)

- Acute erythroleukemia (M6)

- Acute megakaryocytic leukemia (M7)

- Refractory anemia with excess blasts in transformation

- AML with multilineage dysplasia

- In complete remission (CR) or molecular remission (MR) by blood counts and bone
marrow studies* AND meets 1 of the following criteria:

- In first CR after primary induction failure

- Must have received at least 2 induction chemotherapy regimens

- In second or subsequent CR

- In first remission AND > 60 years of age NOTE: *Patients with CR documented by
hematologic parameters are eligible provided current bone marrow studies confirm

- Patients must meet 1 of the following criteria:

- Achieved remission within the past 60 days

- Completed induction or post-remission therapy within the past 60 days

- Achieved hematologic recovery from chemotherapy within the past 60 days

- Extramedullary disease allowed if in CR and not requiring therapy

- No acute promyelocytic leukemia (FAB M3)

- Performance status:

- ECOG 0-2

- Hematopoietic:

- Absolute neutrophil count >= 1,000/mm^3

- Platelet count >= 50,000/mm^3

- Hepatic:

- Bilirubin < 2 mg/dL

- AST and ALT =< 2.5 times upper limit of normal (ULN)

- No active hepatic disease

- Renal:

- Creatinine =< 1.5 times ULN

- No active renal disease

- Cardiovascular:

- No active uncontrolled cardiac disease

- Pulmonary:

- No active uncontrolled pulmonary disease

- No known allergy to imidazole drugs* (e.g., clotrimazole, ketoconazole, miconazole,
econazole, or terconazole)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception NOTE: * Excludes fluconazole,
voriconazole, or itraconazole

- Prior autologous stem cell transplantation allowed

- Prior allogeneic bone marrow transplantation allowed provided treatment did not take
place during the current remission

- Recovered from prior chemotherapy

- Prior consolidation chemotherapy allowed

- No concurrent hepatic enzyme-inducing anticonvulsants

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

From randomization until relapse or death from any cause, up to 5 years

Safety Issue:


Principal Investigator

Selina Luger

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

August 2004

Completion Date:

Related Keywords:

  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Recurrent Adult Acute Myeloid Leukemia
  • Refractory Anemia With Excess Blasts in Transformation
  • Congenital Abnormalities
  • Anemia
  • Anemia, Refractory
  • Anemia, Refractory, with Excess of Blasts
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic
  • Anemia, Aplastic



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Genesis Medical Center - West Campus Davenport, Iowa  52804
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Wilson Medical Center Wilson, North Carolina  27893-3428
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