Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas

StatusActive, Not Recruiting
PhasePhase 2/3
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Apr 1, 2028 → Aug 13, 2028
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Record History

The 50 most recent of 412 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Apr 1, 2028 to Aug 13, 2028 Show 5 more changesShow less
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description revised
    • Site details revised at 53 of 634 sites
    • Publications: details revised at 2 of 2 entries
    • Eligibility criteria shortened, about 5 words
  2. Study sites: 635 to 634v411
  3. Study sites revised (635)v410
  4. Study sites revised (635)v409
  5. 2 versions Re-verified since Jul 7, 2026, no change to tracked fieldsv407-v408
Show 44 earlier versionsHide 44 earlier versions
  1. Study sites revised (635)v406
  2. Study sites: 636 to 635v405
  3. Study sites revised (636)v404
  4. 41 versions Re-verified since Feb 12, 2026, no change to tracked fieldsv363-v403
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II/III trial tests whether it is possible to decrease the chance of high-grade B-cell lymphomas returning or getting worse by adding a new drug, venetoclax to the usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with usual chemotherapy may work better than usual chemotherapy alone in treating patients with high-grade B-cell lymphomas, and may increase the chance of cancer going into remission and not returning.
Trial Details
NCT Number NCT03984448
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Double-Expressor Lymphoma, EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, High Grade B-Cell Lymphoma, Not Otherwise Specified, Neoplastic Cells With Double Expression of MYC and BCL2 Proteins Present, Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
Related terms Lymphoma, Large B-Cell, Diffuse
Enrollment 363 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov