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NCT05633615 · ClinicalTrials.gov registry record · Phase 2

Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

A Phase 2 study of Diffuse Large B Cell Lymphoma and Recurrent Diffuse Large B-Cell Lymphoma, sponsored by SWOG Cancer Research Network.

Recruiting
Registry status
Phase 2
Development phase
396
Enrollment target
20
Study locations

NCT05633615 is a Phase 2 study of Diffuse Large B Cell Lymphoma and Recurrent Diffuse Large B-Cell Lymphoma that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 396 participants, above the 215-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (84% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT05633615, a Phase 2 study of Diffuse Large B Cell Lymphoma and Recurrent Diffuse Large B-Cell Lymphoma, is actively recruiting participants, sponsored by SWOG Cancer Research Network.

RECRUITING
Registry status
Phase 2
Development phase
396 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Diffuse Large B Cell Lymphoma Recurrent Diffuse Large B-Cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma Grade 3b Follicular Lymphoma Primary Mediastinal (Thymic) Large B-Cell Lymphoma Transformed Follic Lymph to Diff Large B-Cell Lymphoma Transformed Marg Zone Lymph to Diff Large B-Cell Lymphoma

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • BIOLOGICAL Axicabtagene Ciloleucel

Study Locations (20)

California

  • UC Irvine Health Cancer Center-Newport - Costa Mesa
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
  • UCI Health Laguna Hills - Laguna Hills
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
  • UCSF Medical Center-Parnassus - San Francisco

Idaho

  • Saint Luke's Cancer Institute - Boise - Boise
  • Saint Luke's Cancer Institute - Fruitland - Fruitland
  • Saint Luke's Cancer Institute - Meridian - Meridian
  • Saint Luke's Cancer Institute - Nampa - Nampa
  • Saint Luke's Cancer Institute - Twin Falls - Twin Falls

Arkansas

  • Highlands Oncology Group - Fayetteville - Fayetteville
  • University of Arkansas for Medical Sciences - Little Rock
  • Highlands Oncology Group - Rogers - Rogers
  • Highlands Oncology Group - Springdale

Arizona

  • Banner University Medical Center - Tucson - Tucson
  • University of Arizona Cancer Center-North Campus - Tucson

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta
  • Emory Saint Joseph's Hospital - Atlanta

Florida

  • UF Health Cancer Institute - Gainesville - Gainesville

Illinois

  • University of Illinois - Chicago

Trial Details

FieldValue
Enrollment Target 396 participants
Start Date 2023-06-12
Est. Completion 2030-06-30
Phase Phase 2

Sponsor

SWOG Cancer Research Network

270 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05633615

The ClinicalTrials.gov registry entry for NCT05633615 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 396 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 (84% higher). The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT05633615 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Idaho, Arkansas.

Frequently Asked Questions

What is clinical trial NCT05633615 about?

NCT05633615 is a clinical study titled "Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma". 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 ...

What is the current status of trial NCT05633615?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 396 participants. The study started on 2023-06-12. Estimated completion is 2030-06-30.

What conditions does trial NCT05633615 study?

This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma, Primary Mediastinal (Thymic) Large B-Cell Lymphoma.

What interventions are being tested in trial NCT05633615?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Axicabtagene Ciloleucel (BIOLOGICAL).

Who is sponsoring clinical trial NCT05633615?

This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05633615 being conducted?

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

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