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NCT03984448 · ClinicalTrials.gov record · last posted 2026-08-04

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
Started2019-10-22
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 407 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 407 times since 2019-06-12; most recent amendment 2026-07-16. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-12-15
Status change Suspended→Active, Not Recruitingv282
2021-08-04
Status change Recruiting→Suspendedv198
2019-10-17
Status change Not Yet Recruiting→Recruitingv3
Trial Details
NCT Number NCT03984448
Lead Sponsor National Cancer Institute (NCI)
Conditions 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
Enrollment 363 participants
Start Date 2019-10-22
Primary Completion 2028-04-01 (estimated)
Study Completion 2028-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-04