Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

StatusCompleted
PhasePhase 3
Started

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Record History

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

  1. Study completion date: Apr 14, 2015v323
  2. Re-verified, no change to tracked fieldsv322
  3. Publications shortened, about 45 wordsv321
  4. Trial status: Active, Not Recruiting to Completedv320 Show 5 more changesShow less
    • Study sites: 221 to 341
    • Primary completion date: Feb 2015 to Feb 20, 2015
    • Start date: Aug 2004 to Aug 18, 2004
    • Eligibility criteria expanded, about 190 words
    • Study description shortened, about 3 words
  5. 2 versions Re-verified since Jun 13, 2016, no change to tracked fieldsv318-v319
Show 44 earlier versionsHide 44 earlier versions
  1. Results first posted: Nov 10, 2015v317 Show 4 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria shortened, about 188 words
    • Secondary endpoint revised
    • Study description expanded, about 1 word
  2. Enrollment target: estimated 139 to confirmed 144
    • Primary completion date: Dec 2014 to Feb 2015
    • Study sites revised (221)
    v316
  3. 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)
    v315
  4. Primary endpoint revisedv314 Show 6 more changesShow less
    • Enrollment target: 141 to 139
    • Study sites: 220 to 219
    • Primary completion date: Jun 2014 to Aug 2014
    • Eligibility criteria expanded, about 295 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 14 words
  5. Enrollment target: estimated 139 to confirmed 141v313
  6. 3 versions Re-verified since May 19, 2014, no change to tracked fieldsv310-v312
  7. Study sites revised (220)v309
  8. Study sites revised (220)v308
  9. Primary completion date: Oct 2013 to Jun 2014
    • Study sites revised (220)
    v307
  10. 2 versions Re-verified since Aug 23, 2013, no change to tracked fieldsv305-v306
  11. Study sites revised (220)v304
  12. Primary completion date: Oct 2012 to Oct 2013v303
  13. Primary completion date: Jun 2012 to Oct 2012v302
  14. Primary completion date: Dec 2009 to Jun 2012v301
  15. Lead sponsor: Eastern Cooperative Oncology Group to National Cancer Institute (NCI)v300 Show 8 more changesShow less
    • Primary endpoint revised
    • Study sites: 174 to 220
    • Primary completion date changed from estimate of Jun 2012 to Dec 2009
    • Interventions: observation (Procedure), tipifarnib (Drug) to clinical observation (Procedure), tipifarnib (Drug)
    • Eligibility criteria shortened, about 31 words
    • Secondary endpoint revised
    • Study description shortened, about 16 words
    • Collaborators shortened, about 4 words
  16. Primary completion date: Jun 2008 to Jun 2012v299
  17. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (174)
    v298
  18. Study sites: 173 to 174v297
  19. Study sites: 172 to 173v296
  20. Study sites: 173 to 172v295
  21. Study sites: 167 to 173v294
  22. Study sites: 175 to 167v293
  23. Study sites: 174 to 175v292
  24. Study sites: 173 to 174v291
  25. Study sites: 172 to 173v290
  26. Study sites: 171 to 172v289
  27. Study sites: 168 to 171v288
  28. Study sites: 171 to 168v287
  29. Study sites: 170 to 171v286
  30. Study sites: 171 to 170v285
  31. Study sites: 170 to 171v284
  32. Study sites: 166 to 170v283
  33. Study sites: 168 to 166v282
  34. Study sites: 167 to 168v281
  35. Study sites: 165 to 167v280
  36. Study sites: 163 to 165v279
  37. Study sites: 145 to 163v278
  38. Study sites: 144 to 145v277
  39. Study sites: 143 to 144v276
  40. Study sites: 142 to 143v275
  41. Study sites: 140 to 142v274
  • 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
(from sponsor)		 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
Related terms Anemia, Refractory, with Excess of Blasts, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov