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NCT03984448 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Diffuse Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
363
Enrollment target
20
Study locations

NCT03984448 is a Phase 2 study of Diffuse Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 363 participants, above the 215-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (69% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT03984448, a Phase 2 study of Diffuse Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
363 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Diffuse Large B Cell Lymphoma Diffuse Large B-Cell Lymphoma, Not Otherwise Specified High Grade B-Cell Lymphoma, Not Otherwise Specified Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified Double-Expressor Lymphoma High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements Neoplastic Cells With Double Expression of MYC and BCL2 Proteins Present

Interventions

  • DRUG Cyclophosphamide
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Biopsy
  • PROCEDURE Computed Tomography
  • DRUG Doxorubicin Hydrochloride

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine - Anchorage
  • Anchorage Radiation Therapy Center - Anchorage
  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Oncology and Hematology LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage
  • Fairbanks Memorial Hospital - Fairbanks

California

  • Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
  • Community Cancer Institute - Clovis
  • University Oncology Associates - Clovis
  • Loma Linda University Medical Center - Loma Linda
  • Fremont - Rideout Cancer Center - Marysville
  • University of California Davis Comprehensive Cancer Center - Sacramento

Arkansas

  • Mercy Hospital Fort Smith - Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs - Hot Springs

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Arizona

  • Cancer Center at Saint Joseph's - Phoenix

Trial Details

FieldValue
Enrollment Target 363 participants
Start Date 2019-10-22
Est. Completion 2028-04-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03984448

The ClinicalTrials.gov registry entry for NCT03984448 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 363 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 215-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (69% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 8 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT03984448 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alaska, California, Arkansas.

Frequently Asked Questions

What is clinical trial NCT03984448 about?

NCT03984448 is a clinical study titled "Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas". 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...

What is the current status of trial NCT03984448?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 363 participants. The study started on 2019-10-22. Estimated completion is 2028-04-01.

What conditions does trial NCT03984448 study?

This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma, Not Otherwise Specified, Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent, EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified.

What interventions are being tested in trial NCT03984448?

The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Doxorubicin Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT03984448?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03984448 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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