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NCT05873712 · ClinicalTrials.gov registry record · Phase 2
Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome
A Phase 2 study of Recurrent Transformed Chronic Lymphocytic Leukemia and Recurrent Transformed Non-Hodgkin Lymphoma, sponsored by Aseel Alsouqi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 3
- Study locations
NCT05873712 is a Phase 2 study of Recurrent Transformed Chronic Lymphocytic Leukemia and Recurrent Transformed Non-Hodgkin Lymphoma that is actively recruiting participants, run by Aseel Alsouqi. The registered enrollment target is 24 participants, below the 32-participant average among 8 other Recurrent Transformed Chronic Lymphocytic Leukemia trials with a reported enrollment target (25% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT05873712, a Phase 2 study of Recurrent Transformed Chronic Lymphocytic Leukemia and Recurrent Transformed Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by Aseel Alsouqi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial tests how well zanubrutinib and lisocabtagene maraleucel (liso-cel) work together in treating patients with Richter's syndrome that has come back (recurrent) or does not respond to treatment (refractory). Richter's syndrome occurs when chronic lymphocytic leukemia and/or small lymphocytic leukemia transforms into an aggressive lymphoma, which is a cancer of the lymph nodes. Zanubrutinib is a class of medication called a kinase inhibitor. These drugs work by preventing the action of abnormal proteins that tell cancer cells to multiply, which helps stop the spread of cancer. Liso-cel is a type of treatment known as chimeric antigen receptor (CAR) T cell therapy. 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 (CAR). 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 zanubrutinib and liso-cell together may kill more cancer cells in patients with recurrent or refractory Richter's syndrome.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
Study Locations (3)
New York
- Icahn School of Medicine at Mount Sinai - New York
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Utah
- Huntsman Cancer Institute - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-07-28 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05873712
The ClinicalTrials.gov registry entry for NCT05873712 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 32-participant average among 8 other Recurrent Transformed Chronic Lymphocytic Leukemia trials with a reported enrollment target (25% lower). The listed sponsor is Aseel Alsouqi, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Recurrent Transformed Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05873712 reports 3 study locations spanning 3 distinct geographic areas - top geographies include New York, Ohio, Utah.
Frequently Asked Questions
What is clinical trial NCT05873712 about?
NCT05873712 is a clinical study titled "Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome". This phase II trial tests how well zanubrutinib and lisocabtagene maraleucel (liso-cel) work together in treating patients with Richter's syndrome that has come back (recurrent) or does not respond to treatment (refractory). Richter's syndrome occurs when chronic lymphocytic leukemia and/or small ly...
What is the current status of trial NCT05873712?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2023-07-28. Estimated completion is 2026-12-31.
What conditions does trial NCT05873712 study?
This clinical trial studies the following conditions: Recurrent Transformed Chronic Lymphocytic Leukemia, Recurrent Transformed Non-Hodgkin Lymphoma, Refractory Transformed Chronic Lymphocytic Leukemia, Recurrent Transformed B-Cell Non-Hodgkin Lymphoma, Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma.
What interventions are being tested in trial NCT05873712?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE).
Who is sponsoring clinical trial NCT05873712?
This trial is sponsored by Aseel Alsouqi, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05873712 being conducted?
This trial has 3 study locations across New York, Ohio, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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