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NCT05718869 · ClinicalTrials.gov registry record · Phase 2
Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study
A Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 3
- Study locations
NCT05718869: Active Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by City of Hope Medical Center.
NCT05718869 is a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 26 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (86% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05718869, a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial tests how well tafasitamab and zanubrutinib works in treating patients with newly diagnosed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply. This may stop the growth and spread of cancer cells. Giving tafasitamab and zanubrutinib in combination may kill more cancer cells in patients with CLL/SLL than giving either treatment alone.
Primary Outcome
Defined as the proportion of response evaluable patients who achieve a complete response according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 guidelines on study before any documented disease progression or any subsequent chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) treatment. CR rate will be estimated by the proportion of response-evaluable patients achieving CR, along with the 95% exact binomial confidence interval.
Conditions Studied
Interventions
- DRUG Zanubrutinib
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- BIOLOGICAL Tafasitamab
Study Locations (3)
California
- City of Hope Medical Center - Duarte
- City of Hope at Irvine Lennar - Irvine
Florida
- University of Miami Sylvester Comprehensive Cancer Center - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2023-05-18 |
| Est. Completion | 2026-04-19 |
| Phase | Phase 2 |
What the registry record for NCT05718869 still lists
NCT05718869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Zanubrutinib is the first listed.
NCT05718869 reports a single indexed study location in California, Florida.
Frequently Asked Questions
What is clinical trial NCT05718869 about?
NCT05718869 is a clinical study titled "Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study". This phase II trial tests how well tafasitamab and zanubrutinib works in treating patients with newly diagnosed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutin...
What is the current status of trial NCT05718869?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2023-05-18. Estimated completion is 2026-04-19.
What conditions does trial NCT05718869 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT05718869?
The interventions under investigation include: Zanubrutinib (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Tafasitamab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05718869?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05718869 being conducted?
This trial has 3 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
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 NCT05718869's enrollment target sits among peer trials
26 147th of 187 higher than 40 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia 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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