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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: Active Phase 2 study of Diffuse Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be compared between the experimental and control arms using a stratified log-rank test. If one of the strata has 0 events or there are numerical issues due to the sparseness of the date within strata, an unstratified log-rank test will be used. The Kaplan-Meier method will be used to estimate PFS distributions. One-year PFS estimates, medians, and corresponding hazard ratios will be provided with 95% confidence intervals for each of the double hit lymphoma (DHL) and double expressing lympho
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2019-10-22 |
| Est. Completion | 2028-04-01 |
| Phase | Phase 2 |
What the registry record for NCT03984448 still lists
NCT03984448 is an interventional study that assigns participants to a tested intervention. The registered 363 participants enrollment target is mid-sized for trials with a published cap, above the 215-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (69% higher).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03984448's enrollment target sits among peer trials
363 15th of 114 higher than 100 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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