Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04231877 · ClinicalTrials.gov registry record · Phase 1
Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma
A Phase 1 study of Primary Mediastinal Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, sponsored by University of Washington.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT04231877: Recruiting Phase 1 study of Primary Mediastinal Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, sponsored by University of Washington.
NCT04231877 is a Phase 1 study of Primary Mediastinal Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified that is actively recruiting participants, run by University of Washington. The registered enrollment target is 56 participants, roughly in line with the 57-participant average among 11 other Primary Mediastinal Large B Cell Lymphoma trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04231877, a Phase 1 study of Primary Mediastinal Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Glofitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Drugs used in combination chemotherapy such as etoposide, cyclophosphamide, and doxorubicin 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. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving polatuzumab vedotin in combination chemotherapy with or without glofitamab may help treat patients with aggressive large B-cell lymphoma.
Primary Outcome
Will estimate the safety and tolerability of polatuzumab vedotin when added to dose-adjusted-etoposide, prednisone, vincristine (Oncovin), cyclophosphamide, doxorubicin-rituximab (DA-EPCH-R) with or without glofitamab, chemoimmunotherapy.
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Etoposide
- DRUG Prednisone
- BIOLOGICAL Rituximab
- DRUG Polatuzumab Vedotin
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2020-10-27 |
| Est. Completion | 2031-12-01 |
| Phase | Phase 1 |
What NCT04231877 shows while recruiting
NCT04231877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 57-participant average among 11 other Primary Mediastinal Large B Cell Lymphoma trials with a reported enrollment target.
The record links to 9 conditions, with Primary Mediastinal Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Doxorubicin is the first listed.
NCT04231877 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT04231877 about?
NCT04231877 is a clinical study titled "Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma". This phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a mono...
What is the current status of trial NCT04231877?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2020-10-27. Estimated completion is 2031-12-01.
What conditions does trial NCT04231877 study?
This clinical trial studies the following conditions: Primary Mediastinal Large B Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, High Grade B-Cell Lymphoma, Not Otherwise Specified, Aggressive Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT04231877?
The interventions under investigation include: Doxorubicin (DRUG), Etoposide (DRUG), Prednisone (DRUG), Rituximab (BIOLOGICAL), Polatuzumab Vedotin (DRUG).
Who is sponsoring clinical trial NCT04231877?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04231877 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Mediastinal Large B Cell Lymphoma
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 NCT04231877's enrollment target sits among peer trials
56 3rd of 11 higher than 9 of 11 other Primary Mediastinal Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Mediastinal 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
RECRUITING · Phase 1
-
Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma
RECRUITING · Phase 1
-
19(T2)28z1xx Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Cancers
ACTIVE NOT RECRUITING · Phase 1
-
CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies
COMPLETED · Phase 1
-
TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
COMPLETED · Phase 1
-
Pembro Plus CAR T-cell Therapy in R/R in PMBCL
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02287428 · 56 participants · Phase 1
Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM
- NCT02923011 · 56 participants · Phase 3
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
- NCT02935283 · 56 participants
Neuroimaging and Neuropsychological Outcomes in Urea Cycle Disorders
- NCT03375866 · 56 participants · NA
Effects of Mixed Nut Consumption on Satiety and Weight Management
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI