Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 1, 2027 → Sep 1, 2028
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 139 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 2 of 114 sites
  2. Study sites: 113 to 114
  3. Site details revised at 1 of 113 sites
  4. Site details revised at 3 of 113 sites
  5. Trial sites expanded: 104 → 113 locations
    • Site details revised at 1 of 113 sites
  6. Study sites: 104 to 113
  7. Trial sites expanded: 96 → 104 locations
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 7 of 8 entries
    • Study description revised
  8. Site details revised at 2 of 96 sitesv132
  9. Site details revised at 3 of 96 sitesv131
  10. Trial sites expanded: 87 → 96 locations
    • Site details revised at 3 of 96 sites
    v130
  11. Primary and study completion pushed from Sep 1, 2027 to Sep 1, 2028
    • Study sites: 87 to 96
    v129
  12. Primary and study completion dates: Sep 1, 2027 to Sep 1, 2028v128
  13. Site details revised at 2 of 87 sitesv127
  14. Site details revised at 2 of 87 sitesv126
  15. Study sites: 86 to 87v125
  16. Site details revised at 2 of 86 sitesv124
  17. Study sites: 85 to 86v123
  18. Study sites: 84 to 85v122
  19. Re-verified, no change to tracked fieldsv121
  20. Study sites: 83 to 84v120
  21. Eligibility criteria expanded, about 14 words
    • Site details revised at 5 of 83 sites
    v119
  22. Re-verified, no change to tracked fieldsv118
  23. Study sites: 82 to 83v117
  24. Site details revised at 2 of 82 sitesv116
  25. Site details revised at 1 of 82 sitesv115
  26. Site details revised at 1 of 82 sitesv114
  27. Trial sites expanded: 72 → 82 locationsv113
  28. Site details revised at 2 of 72 sitesv112
  29. Site details revised at 5 of 72 sitesv111
  30. Re-verified, no change to tracked fieldsv110
  31. Site details revised at 5 of 72 sitesv109
  32. Study sites: 71 to 72v108
  33. Re-verified, no change to tracked fieldsv107
  34. Study sites: 70 to 71v106
  35. Re-verified, no change to tracked fieldsv105
  36. Site details revised at 3 of 70 sitesv104
  37. Re-verified, no change to tracked fieldsv103
  38. Study sites: 69 to 70v102
  39. Site contacts updated at 5 of 69 sitesv101
  40. 6 versions Re-verified since Mar 18, 2026, no change to tracked fieldsv95-v100
  41. Study sites: 68 to 69v94
  42. Re-verified, no change to tracked fieldsv93
  43. Site details revised at 3 of 68 sitesv92
  44. Site details revised at 2 of 68 sitesv91
  45. Re-verified, no change to tracked fieldsv90
  • 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 tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.
Trial Details
NCT Number NCT06649812
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements, Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified, Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma +7 more
Related terms Lymphoma, Large B-Cell, Diffuse
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov