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NCT05455697 · ClinicalTrials.gov registry record · Phase 1
Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma
A Phase 1 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma, sponsored by University of Washington.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT05455697: Recruiting Phase 1 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma, sponsored by University of Washington.
NCT05455697 is a Phase 1 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma that is actively recruiting participants, run by University of Washington. The registered enrollment target is 35 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05455697, a Phase 1 study of Diffuse Large B Cell Lymphoma and High Grade B-Cell Lymphoma, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial tests the safety of tafasitamab, retifanlimab, and rituximab (TRR) as a prephase treatment and in combination with standard therapy consisting off cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or polatuzumab vedotin, cyclophosphamide, doxorubicin, and prednisone (PolaCHP) in patients with untreated diffuse large B-cell lymphoma. Tafasitamab, retifanlimab, and rituximab are monoclonal antibodies. Tafasitamab binds to a protein called CD19, which is found on B-cells (a type of white blood cell) and some types of cancer cells. Rituximab binds to a protein called CD20, which is also found on B-cells and some cancer cells. These monoclonal antibodies may help the immune system kill cancer cells. Immunotherapy with other monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as CHOP and PolaCHP, 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 TRR in combination with CHOP or PolaCHP may kill more cancer cells.
Primary Outcome
Statistical analysis will entail descriptive statistics of adverse event rates. Will build a Cox proportional hazard model for univariate analysis and multivariable analysis if applicable. Correlative studies may incorporate t-test and linear regression for continuous variables, Chi-squared test and logistic regression for categorical variables will be used, if applicable.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Bone Marrow Biopsy
- DRUG Doxorubicin
- DRUG Prednisone
- BIOLOGICAL Retifanlimab
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2023-01-26 |
| Est. Completion | 2027-07-06 |
| Phase | Phase 1 |
What NCT05455697 shows while recruiting
NCT05455697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (84% lower).
The record links to 3 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05455697 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT05455697 about?
NCT05455697 is a clinical study titled "Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma". This phase I/II trial tests the safety of tafasitamab, retifanlimab, and rituximab (TRR) as a prephase treatment and in combination with standard therapy consisting off cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or polatuzumab vedotin, cyclophosphamide, doxorubicin, and predni...
What is the current status of trial NCT05455697?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2023-01-26. Estimated completion is 2027-07-06.
What conditions does trial NCT05455697 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, High Grade B-Cell Lymphoma, Grade 3b Follicular Lymphoma.
What interventions are being tested in trial NCT05455697?
The interventions under investigation include: Cyclophosphamide (DRUG), Bone Marrow Biopsy (PROCEDURE), Doxorubicin (DRUG), Prednisone (DRUG), Retifanlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05455697?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05455697 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
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Where NCT05455697's enrollment target sits among peer trials
35 75th of 114 higher than 40 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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