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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: Recruiting Phase 2 study of Recurrent Transformed Chronic Lymphocytic Leukemia and Recurrent Transformed Non-Hodgkin Lymphoma, sponsored by Aseel Alsouqi.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall response rate (ORR) will be defined as the proportion of patients achieving a complete or partial response divided by the number of efficacy-evaluable patients according to the Revised Response Criteria for Malignant Lymphoma. Response will be assessed using Lugano criteria 2014. ORR will be reported with two-sided 95% and 80% binomial exact confidence intervals.
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 |
What NCT05873712 shows while recruiting
NCT05873712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 32-participant average among 8 other Recurrent Transformed Chronic Lymphocytic Leukemia trials with a reported enrollment target (25% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Recurrent Transformed 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 NCT05873712's enrollment target sits among peer trials
24 6th of 8 higher than 2 of 8 other Recurrent Transformed Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Transformed 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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