OncRef

Clinical Trial: NCT03984448

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-19

Study Overview

Brief Summary

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.

Official Title

Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas

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

Intervention / Treatment

  • Procedure: Biospecimen Collection
  • Procedure: Bone Marrow Biopsy
  • Procedure: Computed Tomography
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin Hydrochloride
  • Drug: Etoposide
  • Procedure: Lumbar Puncture
  • Procedure: Positron Emission Tomography
  • Drug: Prednisone
  • Biological: Rituximab
  • Drug: Venetoclax
  • Drug: Vincristine Sulfate

Other Study ID Numbers

  • NCI-2019-03711
  • NCI-2019-03711
  • A051701
  • A051701
  • U10CA180821

Start Date (Actual)

2019-10-22

Primary Completion Date (Estimated)

2028-08-13

Study Completion Date (Estimated)

2028-08-13

Enrollment (Estimated)

363

Study Type

Interventional

Phase

Phase 2, Phase 3