S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma

StatusCompleted
PhasePhase 3
Started

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Record History

The 50 most recent of 238 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial status: Active, Not Recruiting to Completed
    • Site details revised at 1 of 259 sites
    v238
  2. Study completion date: Mar 2025 to Dec 2025v237
  3. Study completion date: Mar 2024 to Mar 2025v236
  4. Study completion date: Jun 2023 to Mar 2024v235
  5. 4 versions Re-verified since Jul 15, 2019, no change to tracked fieldsv231-v234
Show 42 earlier versionsHide 42 earlier versions
  1. Study completion date: Jun 2018 to Jun 2023
    • Site details revised at 1 of 259 sites
    v230
  2. Study completion date: Jun 2017 to Jun 2018v229
  3. Study completion date: Jun 2017
    • Interventions: cyclophosphamide (Drug), doxorubicin hydrochloride (Drug), prednisone (Drug), rituximab (Biological), tositumomab and iodine I 131… to cyclophosphamide (Drug), doxorubicin (Drug), prednisone (Drug), rituximab (Biological), tositumomab (Radiation), vincristine (Drug)
    • Site details revised at 2 of 259 sites
    • Study title shortened, about 3 words
    v228
  4. 2 versions Re-verified since Feb 21, 2014, no change to tracked fieldsv226-v227
  5. Results first posted: Feb 26, 2013v225 Show 5 more changesShow less
    • Primary endpoints: 1 to 4
    • Enrollment target: estimated 500 to confirmed 571
    • Primary completion date: Sep 2011
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints revised (2)
  6. Study title expanded, about 1 wordv224
  7. Primary completion date: Aug 2004 to not statedv223
  8. Re-verified, no change to tracked fieldsv222
  9. Interventions: cyclophosphamide (Drug), doxorubicin hydrochloride (Drug), prednisone (Drug), rituximab (Drug), tositumomab and iodine I 131 tositumomab… to cyclophosphamide (Drug), doxorubicin hydrochloride (Drug), prednisone (Drug), rituximab (Biological), tositumomab and iodine I 131…v221
  10. 2 versions Re-verified since Jan 1, 2009, no change to tracked fieldsv219-v220
  11. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (259)
    v218
  12. Study sites: 260 to 259v217
  13. Study sites: 258 to 260v216
  14. Study sites: 259 to 258v215
  15. Study sites: 258 to 259v214
  16. Study sites: 261 to 258v213
  17. Study sites: 262 to 261v212
  18. Study sites: 263 to 262v211
  19. Study sites: 262 to 263v210
  20. Study sites: 261 to 262v209
  21. Site details revised at 1 of 261 sitesv208
  22. Study sites: 263 to 261v207
  23. Study sites: 262 to 263
    • Interventions: cyclophosphamide (Drug), doxorubicin hydrochloride (Drug), prednisone (Drug), rituximab (Drug), tositumomab and iodine I 131 tositumomab… to cyclophosphamide (Drug), doxorubicin hydrochloride (Drug), prednisone (Drug), rituximab (Drug), tositumomab and iodine I 131 tositumomab…
    v206
  24. Study sites: 263 to 262v205
  25. Study sites: 262 to 263v204
  26. Study sites: 263 to 262v203
  27. Study sites: 262 to 263v202
  28. Site contacts updated at 2 of 262 sitesv201
  29. Study sites revised (262)v200
  30. Study sites: 263 to 262v199
  31. Study sites: 264 to 263v198
  32. Study sites: 259 to 264v197
  33. Study sites: 255 to 259v196
  34. Study sites: 256 to 255v195
  35. Study sites: 261 to 256v194
  36. Study sites: 260 to 261v193
  37. Site details revised at 1 of 260 sitesv192
  38. Study sites: 261 to 260v191
  39. Study sites: 264 to 261v190
  40. Study sites: 267 to 264v189
  • 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.
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.
Trial Details
NCT Number NCT00006721
Lead Sponsor SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI), Cancer and Leukemia Group B, Eastern Cooperative Oncology Group
Conditions
(from sponsor)		 Lymphoma
Related terms Lymphoma, Lymphoma, Follicular
Enrollment 571 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov