Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease

StatusCompleted
PhasePhase 2
Started

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Record History

The 50 most recent of 391 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Start date: Jan 2, 2006 to Mar 10, 2006v391 Show 4 more changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Primary completion date: Oct 6, 2015 to Jun 30, 2015
    • Study completion date changed from estimate of Dec 31, 2030 to Mar 31, 2026
    • Study sites revised (170)
  2. Re-verified, no change to tracked fieldsv390
  3. Study sites revised (170)v389
  4. Study sites revised (170)v388
  5. Phase: Not applicable to Phase 2v387 Show 7 more changesShow less
    • Primary completion date: Nov 2012 to Oct 6, 2015
    • Study sites: 114 to 170
    • Study completion date: Dec 31, 2030
    • Start date: Jan 2006 to Jan 2, 2006
    • Interventions: conventional surgery (Procedure), cyclophosphamide (Drug), doxorubicin hydrochloride (Drug), prednisone (Drug), radiation therapy… to Conventional Surgery (Procedure), Cyclophosphamide (Drug), Doxorubicin Hydrochloride (Drug), Prednisone (Drug), Radiation Therapy…
    • Eligibility criteria shortened, about 6 words
    • Study description expanded, about 18 words
Show 45 earlier versionsHide 45 earlier versions
  1. Secondary endpoints: details revised at 1 of 4 entriesv386
  2. Primary endpoint revised
    • Enrollment target: 194 to 188
    • Secondary endpoints: details revised at 1 of 4 entries
    v385
  3. Results first posted: Aug 10, 2016
    • Secondary endpoints revised (4)
    • Primary endpoint revised
    v384
  4. Enrollment target: 188 to 194v383 Show 4 more changesShow less
    • Study sites: 102 to 114
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description revised
  5. Primary endpoints: 2 to 1v382 Show 4 more changesShow less
    • Primary completion date: Sep 2013 to Nov 2012
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: 2 to 4
    • Study description shortened, about 18 words
  6. Enrollment target: estimated 150 to confirmed 188
    • Eligibility criteria revised
    v381
  7. Study sites: 146 to 102v380 Show 6 more changesShow less
    • Interventions: CHOP regimen (Drug), conventional surgery (Procedure), cyclophosphamide (Drug), doxorubicin hydrochloride (Drug), prednisone (Drug)… to conventional surgery (Procedure), cyclophosphamide (Drug), doxorubicin hydrochloride (Drug), prednisone (Drug), radiation therapy…
    • Eligibility criteria expanded, about 124 words
    • Study description expanded, about 6 words
    • Publications: 2 to 1
    • Study title revised
    • Study arms: 0 to 1
  8. Primary completion date: Feb 2010 to Sep 2013
    • Publications: 1 to 2
    • Eligibility criteria shortened, about 1 word
    v379
  9. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 146 of 146 sites
    v378
  10. Study sites revised (146)v377
  11. Re-verified, no change to tracked fieldsv376
  12. Study sites revised (146)v375
  13. Re-verified, no change to tracked fieldsv374
  14. Study sites: 145 to 146v373
  15. Study sites: 146 to 145v372
  16. Study sites: 145 to 146v371
  17. Study sites: 146 to 145v370
  18. Study sites: 145 to 146v369
  19. Study sites: 146 to 145v368
  20. Study sites: 145 to 146v367
  21. Study sites: 146 to 145v366
  22. Study sites: 145 to 146v365
  23. Study sites: 147 to 145v364
  24. Study sites: 146 to 147v363
  25. Study sites: 147 to 146v362
  26. Study sites: 146 to 147v361
  27. Study sites: 147 to 146v360
  28. Study sites: 146 to 147v359
  29. Study sites: 147 to 146v358
  30. Study sites: 146 to 147v357
  31. Study sites: 147 to 146v356
  32. Study sites: 146 to 147v355
  33. Study sites: 147 to 146v354
  34. Study sites: 146 to 147v353
  35. Study sites: 147 to 146v352
  36. Study sites: 146 to 147v351
  37. Study sites: 145 to 146v350
  38. Study sites revised (145)v349
  39. Study sites: 142 to 145v348
  40. Study sites: 144 to 142v347
  41. Study sites: 143 to 144v346
  42. Study sites: 144 to 143v345
  43. Study sites: 143 to 144v344
  44. Study sites: 144 to 143v343
  45. Study sites: 143 to 144v342
  • 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 phase II trial is studying how well surgery and/or combination chemotherapy with or without radiation therapy or observation only work in treating young patients with newly diagnosed stage I or stage II lymphocyte predominant Hodgkin disease (LPHD). Surgery may be an effective treatment for LPHD. Drugs used in chemotherapy, such as doxorubicin, vincristine, prednisone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more cancer cells.
Trial Details
NCT Number NCT00107198
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Ann Arbor Stage I Childhood Hodgkin Lymphoma, Ann Arbor Stage II Childhood Hodgkin Lymphoma, Childhood Nodular Lymphocyte Predominant B-Cell Lymphoma
Enrollment 188 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov