Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Public ClinicalTrials.gov record NCT05633615. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-Cell Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma or Grade IIIB Follicular Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, 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. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them.
Study identification
- NCT ID
- NCT05633615
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 396 participants
Conditions and interventions
Conditions
- Diffuse Large B-Cell Lymphoma
- Grade 3b Follicular Lymphoma
- Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Recurrent Diffuse Large B-Cell Lymphoma
- Refractory Diffuse Large B-Cell Lymphoma
- Transformed Follic Lymph to Diff Large B-Cell Lymphoma
- Transformed Marg Zone Lymph to Diff Large B-Cell Lymphoma
Interventions
- Axicabtagene Ciloleucel Biological
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Cyclophosphamide Drug
- Fludarabine Drug
- Lisocabtagene Maraleucel Biological
- Mosunetuzumab Biological
- Patient Observation Other
- Polatuzumab Vedotin Drug
- Positron Emission Tomography Procedure
- Tisagenlecleucel Biological
Biological · Procedure · Drug + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 11, 2023
- Primary completion
- Jun 29, 2030
- Completion
- Jun 29, 2030
- Last update posted
- Feb 1, 2026
2023 – 2030
United States locations
- U.S. sites
- 87
- U.S. states
- 27
- U.S. cities
- 70
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | Recruiting |
| University of Arizona Cancer Center-North Campus | Tucson | Arizona | 85719 | Recruiting |
| Highlands Oncology Group - Fayetteville | Fayetteville | Arkansas | 72703 | Recruiting |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | Recruiting |
| Highlands Oncology Group - Rogers | Rogers | Arkansas | 72758 | Recruiting |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | Recruiting |
| UC Irvine Health Cancer Center-Newport | Costa Mesa | California | 92627 | Recruiting |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | 92612 | Recruiting |
| UCI Health Laguna Hills | Laguna Hills | California | 92653 | Recruiting |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | Recruiting |
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | Recruiting |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | Recruiting |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | Recruiting |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | Recruiting |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | Recruiting |
| Saint Luke's Cancer Institute - Fruitland | Fruitland | Idaho | 83619 | Recruiting |
| Saint Luke's Cancer Institute - Meridian | Meridian | Idaho | 83642 | Recruiting |
| Saint Luke's Cancer Institute - Nampa | Nampa | Idaho | 83687 | Recruiting |
| Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | 83301 | Recruiting |
| University of Illinois | Chicago | Illinois | 60612 | Recruiting |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | Recruiting |
| Loyola University Medical Center | Maywood | Illinois | 60153 | Suspended |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | Recruiting |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | Recruiting |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | Recruiting |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | Recruiting |
| The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | 40202 | Recruiting |
| UofL Health Medical Center Northeast | Louisville | Kentucky | 40245 | Recruiting |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | Recruiting |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | Recruiting |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | Recruiting |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Recruiting |
| Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | Recruiting |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | Recruiting |
| Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan | 49503 | Recruiting |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | Recruiting |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | Recruiting |
| Beacon Kalamazoo Cancer Center | Kalamazoo | Michigan | 49009 | Recruiting |
| Trinity Health Muskegon Hospital | Muskegon | Michigan | 49444 | Recruiting |
| Corewell Health Lakeland Hospitals - Niles Hospital | Niles | Michigan | 49120 | Recruiting |
| Cancer and Hematology Centers of Western Michigan - Norton Shores | Norton Shores | Michigan | 49444 | Recruiting |
| Corewell Health Reed City Hospital | Reed City | Michigan | 49677 | Recruiting |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | Recruiting |
| Henry Ford Health Providence Southfield Hospital | Southfield | Michigan | 48075 | Active, not recruiting |
| Munson Medical Center | Traverse City | Michigan | 49684 | Recruiting |
| University of Michigan Health - West | Wyoming | Michigan | 49519 | Recruiting |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | Recruiting |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | Recruiting |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | Recruiting |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | Suspended |
| University of Rochester | Rochester | New York | 14642 | Recruiting |
| Wilmot Cancer Institute at Webster | Webster | New York | 14580 | Recruiting |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | Recruiting |
| Atrium Health Cabarrus/LCI-Concord | Concord | North Carolina | 28025 | Recruiting |
| Duke University Medical Center | Durham | North Carolina | 27710 | Suspended |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | Recruiting |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | Recruiting |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | Recruiting |
| Case Western Reserve University | Cleveland | Ohio | 44106 | Recruiting |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | Recruiting |
| Providence Willamette Falls Medical Center | Oregon City | Oregon | 97045 | Recruiting |
| Providence Portland Medical Center | Portland | Oregon | 97213 | Recruiting |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | Recruiting |
| Oregon Health and Science University | Portland | Oregon | 97239 | Recruiting |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | Recruiting |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | Recruiting |
| Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | 29316 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| Prisma Health Cancer Institute - Easley | Easley | South Carolina | 29640 | Recruiting |
| Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | 29605 | Recruiting |
| Prisma Health Cancer Institute - Faris | Greenville | South Carolina | 29605 | Recruiting |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | Recruiting |
| Prisma Health Cancer Institute - Greer | Greer | South Carolina | 29650 | Recruiting |
| Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | 29672 | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee | 38120 | Recruiting |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | Recruiting |
| University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | Recruiting |
| Dartmouth Cancer Center - North | Saint Johnsbury | Vermont | 05819 | Recruiting |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | Recruiting |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122 | Recruiting |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center | Madison | Wisconsin | 53718 | Recruiting |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
| Froedtert and MCW Moorland Reserve Health Center | New Berlin | Wisconsin | 53151 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05633615, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 1, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05633615 live on ClinicalTrials.gov.