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Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 323 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Completion date: Apr 14, 2015

    Study Statusv323

  2. Minor

    Study Status, References

    Re-verified, no change to tracked fields

    v322

  3. Minor

    Publications shortened, about 45 words

    Show what changed: Publications
    E2902: A Phase III randomized study of farnesyl transferase inhibitor R115777 in acute myeloid leukemia patients in second or subsequent remission or in remission after primary induction failure or patients over age 60 in first remission. Clin Adv Hematol Oncol. 2007 Jan;5(1):13-4. No abstract avail [...]

    Study Status, References, Outcome Measures (Results)v321

  4. Minor

    Trial status: Active, Not Recruiting to Completed

    Study sites: 221 to 341; Primary completion date: Feb 2015 to Feb 20, 2015; Start date: Aug 2004 to Aug 18, 2004; and 2 more

    Show all 6 changes in this update
    • Minor Trial status: Active, Not Recruiting to Completed
    • Minor Study sites: 221 to 341
    • Minor Primary completion date: Feb 2015 to Feb 20, 2015
    • Minor Start date: Aug 2004 to Aug 18, 2004
    • Minor Eligibility criteria expanded, about 190 words
      Show what changed
      [...] ients in first remission following primary induction failure Patients andmust have received at least two chemotherapy induction regimens [...] criteria Acute myeloid leukemia with multilineage dysplasia Patients with acute promyelocytic leukemia (FAB M3) are not eligible Patients must be registered within 60 days of completion of therapy for the current remission; patients are eligible if they meet any of the criteria below: Within 60 days of remission (CR or MR) by peripheral blood counts following induction therapy or Within 60 days of discharge from the hospital following induction therapy or Wit [...] [...]
    • Minor Study description shortened, about 3 words
      Show what changed
      [...] ith respect to disease-free survival (DFS) in patients with acute myeloid leukemia (AML) in second or subsequent complete remission or in complete r [...]

    Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, Contacts/Locations, Baseline Characteristics, Outcome Measures (Results)v320

  5. Minor

    2 amendments

    2 re-verifications since 2016-06-13, no change to tracked fields

    v318-v319

Show 44 earlier versions

  1. Notable

    Results first posted: Nov 10, 2015

    Primary endpoint revised; Eligibility criteria shortened, about 188 words; Secondary endpoint revised; and 1 more

    Show all 5 changes in this update
    • Notable Results first posted: Nov 10, 2015
    • Notable Primary endpoint revised
      Show what changed
      Disease-free survival (DFS)Survival
    • Minor Eligibility criteria shortened, about 188 words
      Show what changed
      [...] ients in first remission following primary induction failure Patients mustand have received at least two chemotherapy induction regimens [...] ients > 60 years old in first remission Patients must be in complete remission (CR) or MR (morphologic remission (MR) by blood counts and bone marrow studies to enter the study [...] criteria Acute myeloid leukemia with multilineage dysplasia Patients with acute promyelocytic leukemia (FAB M3) are not eligible Patients must be registered within 60 days of completion of therapy for the current remission; patients are eligible if they meet any of the criteria below: W [...] [...]
    • Minor Secondary endpoint revised
      Show what changed
      Overall survivalSurvival
    • Minor Study description expanded, about 1 word
      Show what changed
      [...] py to observation only with respect to disease-free survival (DFS) in patients with acute myeloid leukemia (AML) in second or [...] LINE: Patients are randomized to 1 of 2 treatment arms. ARM IA: Patients receive tipifarnib orally (PO) twice daily (BID) [...] bsence of disease progression or unacceptable toxicity. ARM IIB: Patients undergo observation only. After completion of study treatment, patients are followed up for 5 years.

    Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Eventsv317

  2. Minor

    Enrollment target: estimated 139 to confirmed 144

    Primary completion date: Dec 2014 to Feb 2015; Study sites revised (221)

    Show what changed: Study sites
    University of Chicago Comprehensive Cancer Center Ohio State University MedicalComprehensive Cancer Center University of Vermont College of Medicine ColumbiaKadlec BasinClinic Hematology and Oncology PLLC Wenatchee Valley MedicalHospital Centerand Clinics

    Study Status, Study Design, Arms and Interventions, Contacts/Locationsv316

  3. Minor

    Study sites: 219 to 221

    Primary completion date changed from estimate of Aug 2014 to Dec 2014; Interventions: clinical observation (Procedure), tipifarnib (Drug) to Clinical Observation (Procedure), Tipifarnib (Drug)

    Study Identification, Study Status, Conditions, Arms and Interventions, Contacts/Locationsv315

  4. Notable

    Primary endpoint revised

    Enrollment target: 141 to 139; Study sites: 220 to 219; Primary completion date: Jun 2014 to Aug 2014; and 3 more

    Show all 7 changes in this update
    • Notable Primary endpoint revised
      Show what changed
      Disease-free survival (DFS)
    • Minor Enrollment target: 141 to 139
    • Minor Study sites: 220 to 219
    • Minor Primary completion date: Jun 2014 to Aug 2014
    • Minor Eligibility criteria expanded, about 295 words
      Show what changed
      Inclusion Criteria: MorphologicallyPatients confirmedeligible acuteto myeloidenter leukemiathis (AML)study must fall into one of 1these categories: Patients in first remission following primary induction failure Patients must have received at least two chemotherapy induction regimens Patients in second or subsequent remission Patients > 60 years old in first remission Patients must be in CR or MR (morphologic remission) by blo [...] of the following types: prior to achievement of CR/MR Acute myeloblastic leukemia, minimal differentiation (French-American-British [FAB] M0) Acute myeloblastic leukemia [...] [...]
    • Minor Secondary endpoints: details revised at 1 of 1 entry
    • Minor Study description shortened, about 14 words
      Show what changed
      PRIMARY OBJECTIVES: I. CompareTo compare R115777 (tipifarnib) maintenance therapy to observation only with respect to disease-free survival in patients with acute myeloid leukemia (AML) in second or subsequent complete remission or in first complete remissionresponse treated(CR) withfollowing tipifarnibprimary asinduction maintenance therapy vs observation alonefailure. SECONDARY OBJECTIVES: I. CompareTo compare overall survival inof patients treatedin withboth these regimensarms. II. DetermineTo evaluate the long-term safety and toxicity of tipifarnibextended administration of R115777 in thes [...] [...]

    Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv314

  5. Minor

    Enrollment target: estimated 139 to confirmed 141

    Study Identification, Study Status, Oversight, Study Design, Contacts/Locationsv313

  6. Minor

    3 amendments

    3 re-verifications since 2014-05-19, no change to tracked fields

    v310-v312

  7. Minor

    Study sites revised (220)

    Show what changed: Study sites
    Indiana UniversityIU Health La Porte Hospital

    Study Status, Contacts/Locationsv309

  8. Minor

    Study sites revised (220)

    Show what changed: Study sites
    Liberty Radiation Oncology ClinicHospital

    Study Status, Contacts/Locationsv308

  9. Notable

    Primary completion date: Oct 2013 to Jun 2014

    Study sites revised (220)

    Show what changed: Study sites
    Saint Anthony Central Hospital Northeast GeorgiaUniversity Cancer Careand Blood Center LLC University of Chicago Comprehensive Cancer Center Evanston CCOP-NorthShore University HealthSystem-Evanston Hospital Valley Radiation Oncology McFarland Clinic PC-William R Bliss Cancer Center McFarland Clinic Medical Oncology and Hematology Associates-Laurel Johns Hopkins University/Sidney Kimmel Cancer Center William Beaumont Hospital-Royal Oak CentraCareCoborn ClinicCancer Center at Saint Cloud Hospital Southeastern Medical Oncology Center-Goldsboro MountainviewCentral Vermont Medical Center/National [...] [...]

    Study Status, Arms and Interventions, Contacts/Locationsv307

  10. Minor

    2 amendments

    2 re-verifications since 2013-08-23, no change to tracked fields

    v305-v306

  11. Minor

    Study sites revised (220)

    Show what changed: Study sites
    Broward GeneralHealth Medical Center Georgia Health SciencesRegents University Illinois CancerCare Galesburg Western Clinic IntercommunityIllinois Cancer Treatment Center Saint Joseph's Regional Medical Center-Mishawaka Siouxland Hematology - Oncology Associates Essentia Health Saint Mary's Medical Center IndependenceCenterpoint Regional HealthMedical Center LLC PeaceHealth Saint Joseph HospitalMedical Center PugetGroup Sound Oncology ConsortiumHealth

    Study Identification, Study Status, Oversight, Study Description, Contacts/Locationsv304

  12. Notable

    Primary completion date: Oct 2012 to Oct 2013

    Study Statusv303

  13. Minor

    Primary completion date: Jun 2012 to Oct 2012

    Study Statusv302

  14. Notable

    Primary completion date: Dec 2009 to Jun 2012

    Study Statusv301

  15. Notable

    Lead sponsor: Eastern Cooperative Oncology Group to National Cancer Institute (NCI)

    Primary endpoint revised; Study sites: 174 to 220; Primary completion date changed from estimate of Jun 2012 to Dec 2009; and 5 more

    Show all 9 changes in this update
    • Notable Lead sponsor: Eastern Cooperative Oncology Group to National Cancer Institute (NCI)
    • Notable Primary endpoint revised
      Show what changed
      Disease-free survival (DSD) measured at years 1.17, 1.67, 2.17, 2.67, 3.17, and 3.67
    • Minor Study sites: 174 to 220
    • Minor Primary completion date changed from estimate of Jun 2012 to Dec 2009
    • Minor Interventions: observation (Procedure), tipifarnib (Drug) to clinical observation (Procedure), tipifarnib (Drug)
    • Minor Eligibility criteria shortened, about 31 words
      Show what changed
      DISEASEInclusion CHARACTERISTICSCriteria: Morphologically confirmed acute myeloid leukemia (AML) of [...] requiring therapy No acute promyelocytic leukemia (FAB M3) PATIENT CHARACTERISTICS: Age 18 and over Performance status: ECOG 0-2 Life expectancy Not specified 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 uncontro [...] [...]
    • Minor Secondary endpoint revised
      Show what changed
      Overall survival at 1-2 years after completion of study treatment
    • Minor Study description shortened, about 16 words
      Show what changed
      PRIMARY OBJECTIVES: Primary I. Compare disease-free survival in patients with acute myeloid [...] ith tipifarnib as maintenance therapy vs observation alone. SecondarySECONDARY OBJECTIVES: I. Compare overall survival in patients treated with these regimens. II. Determine long-term safety and toxicity of tipifarnib in the [...] therapy). Patients are randomized to 1 of 2 treatment arms. ArmARM I: Patients receive oral tipifarnib twice daily on days 1-2 [...] he absence of disease progression or unacceptable toxicity. ArmARM II: Patients undergo observation only. Patients are followed for up to 5 years. PROJECTED AC [...]
    • Minor Collaborators shortened, about 4 words
      Show what changed
      National Cancer Institute (NCI)

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, Referencesv300

  16. Notable

    Primary completion date: Jun 2008 to Jun 2012

    Study Identification, Study Status, Contacts/Locationsv299

  17. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Study sites revised (174)

    Show what changed: Study sites
    city: Alexandria, contacts: [{'name': 'Donald J. Jurgens', 'phone': '320-229-4907', 'role': 'CONTACT'}], country: United States, geoPoint: {'lat': 45.88524, 'lon': -95.37754}, state: Minnesota, status: RECRUITING, zip: 56308 city: Fergus Falls, contacts: [{'name': 'Donald J. Jurgens', 'phone': '320-229-4907', 'role': 'CONTACT'}], country: United States, geoPoint: {'lat': 46.28302, 'lon': -96.07756}, state: Minnesota, status: RECRUITING, zip: 56537 city: Great Falls, contacts: [{'name': 'Benjamin T. Marchello, MD', 'phone': '406-238-6290', 'role': 'CONTACT'}], country: United States, geoPoint: [...] [...]

    Study Status, Contacts/Locationsv298

  18. Minor

    Study sites: 173 to 174

    Study Status, Contacts/Locationsv297

  19. Minor

    Study sites: 172 to 173

    Study Status, Contacts/Locationsv296

  20. Minor

    Study sites: 173 to 172

    Study Status, Contacts/Locationsv295

  21. Minor

    Study sites: 167 to 173

    Study Status, Contacts/Locationsv294

  22. Minor

    Study sites: 175 to 167

    Study Status, Contacts/Locationsv293

  23. Minor

    Study sites: 174 to 175

    Study Status, Contacts/Locationsv292

  24. Minor

    Study sites: 173 to 174

    Study Status, Contacts/Locationsv291

  25. Minor

    Study sites: 172 to 173

    Study Status, Contacts/Locationsv290

  26. Minor

    Study sites: 171 to 172

    Study Status, Contacts/Locationsv289

  27. Minor

    Study sites: 168 to 171

    Study Status, Contacts/Locationsv288

  28. Minor

    Study sites: 171 to 168

    Study Status, Contacts/Locationsv287

  29. Minor

    Study sites: 170 to 171

    Study Status, Contacts/Locationsv286

  30. Minor

    Study sites: 171 to 170

    Study Status, Contacts/Locationsv285

  31. Minor

    Study sites: 170 to 171

    Study Status, Contacts/Locationsv284

  32. Minor

    Study sites: 166 to 170

    Study Status, Contacts/Locationsv283

  33. Minor

    Study sites: 168 to 166

    Study Status, Contacts/Locationsv282

  34. Minor

    Study sites: 167 to 168

    Study Status, Contacts/Locationsv281

  35. Minor

    Study sites: 165 to 167

    Study Status, Contacts/Locationsv280

  36. Minor

    Study sites: 163 to 165

    Study Status, Contacts/Locationsv279

  37. Minor

    Study sites: 145 to 163

    Study Status, Contacts/Locationsv278

  38. Minor

    Study sites: 144 to 145

    Study Status, Contacts/Locationsv277

  39. Minor

    Study sites: 143 to 144

    Study Status, Contacts/Locationsv276

  40. Minor

    Study sites: 142 to 143

    Study Status, Contacts/Locationsv275

  41. Minor

    Study sites: 140 to 142

    Study Status, Contacts/Locationsv274

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized phase III trial studies tipifarnib in treating patients with acute myeloid leukemia (AML) in remission. Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether tipifarnib is more effective than observation alone in preventing the recurrence of AML.
Trial Details
NCT Number NCT00093470
Lead Sponsor National Cancer Institute (NCI)
Conditions Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Megakaryoblastic Leukemia, Adult Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With Maturation, Adult Acute Myeloid Leukemia With Minimal Differentiation, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11 +9 more
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov