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NCT05650723 · ClinicalTrials.gov registry record · Phase 2
Zanubrutinib and Venetoclax as Initial Therapy for Chronic Lymphocytic Leukemia (CLL) With Response-based Obinutuzumab
A Phase 2 study of Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Weill Medical College of Cornell University.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05650723: Active Phase 2 study of Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Weill Medical College of Cornell University.
NCT05650723 is a Phase 2 study of Leukemia, Lymphocytic, Chronic, B-Cell that is active but no longer recruiting, run by Weill Medical College of Cornell University. The registered enrollment target is 50 participants, below the 487-participant average among 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05650723, a Phase 2 study of Leukemia, Lymphocytic, Chronic, B-Cell, is active but no longer recruiting, sponsored by Weill Medical College of Cornell University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Bruton's tyrosine kinase inhibitors (BTKi), anti-CD20 antibodies, and the B cell lymphoma 2 inhibitor (BCL-2i) venetoclax are drug classes used to treat patients with chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL). Anti-CD20 therapy may not be required for all patients. The investigators hypothesis is that it may be better to give anti-CD20 therapy (obinutuzumab) only to patients that still have detectable cancer in their blood (minimal residual disease \[MRD\]) after being treated with a combination of two oral medications, zanubrutinib (a BTKi ) and venetoclax (a BCL-2i), instead of giving a combination of three drugs to all patients from the start of treatment. This strategy, if effective, will prevent overtreatment with anti-CD20 antibodies; reduce side effects of treatment while potentially increasing MRD negativity rates; and will possibly make the anti-CD20 antibody therapy more effective given the low tumor burden present when utilized. This study will test this hypothesis by treating subjects with 3 cycles of a zanubrutinib monotherapy lead-in, in order to debulk and mitigate tumor lysis risk, followed by 13 cycles of zanubrutinib and venetoclax combination therapy. Subjects who are both peripheral blood and bone marrow MRD negative at the completion of the 13 cycles of combination therapy will stop treatment and enter an observation phase every 3 months. Subjects that are MRD positive will continue combination therapy with zanubrutinib and venetoclax for an additional 6 cycles but also receive 6 cycles of obinutuzumab in order to augment response and increase MRD negative rates for the overall treated cohort.
Primary Outcome
The primary endpoint of C16 peripheral blood MRD negativity at cycle 16 will be represented as a percentage of total patients. This will be calculated on both efficacy evaluable and intention to treat basis. These will be estimated with a 90% confidence interval using Clopper-Pearson method based on exact binomial distribution. A cycle is defined as 28 days.
Conditions Studied
Interventions
- DRUG Zanubrutinib Pill
- DRUG Venetoclax Pill
- DRUG Obinutuzumab Injection
Study Locations (1)
New York
- Weill Cornell Medicine/NewYork-Presberteryian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-05-08 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What the registry record for NCT05650723 still lists
NCT05650723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 487-participant average among 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Leukemia, Lymphocytic, Chronic, B-Cell appearing as the primary indexed condition, and to 3 interventions - of which Zanubrutinib Pill is the first listed.
NCT05650723 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05650723 about?
NCT05650723 is a clinical study titled "Zanubrutinib and Venetoclax as Initial Therapy for Chronic Lymphocytic Leukemia (CLL) With Response-based Obinutuzumab". Bruton's tyrosine kinase inhibitors (BTKi), anti-CD20 antibodies, and the B cell lymphoma 2 inhibitor (BCL-2i) venetoclax are drug classes used to treat patients with chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL). Anti-CD20 therapy may not be required for all patients. The invest...
What is the current status of trial NCT05650723?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2023-05-08. Estimated completion is 2027-12.
What conditions does trial NCT05650723 study?
This clinical trial studies the following conditions: Leukemia, Lymphocytic, Chronic, B-Cell.
What interventions are being tested in trial NCT05650723?
The interventions under investigation include: Zanubrutinib Pill (DRUG), Venetoclax Pill (DRUG), Obinutuzumab Injection (DRUG).
Who is sponsoring clinical trial NCT05650723?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05650723 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05650723's enrollment target sits among peer trials
50 10th of 11 higher than 2 of 11 other Leukemia, Lymphocytic, Chronic, B-Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia, Lymphocytic, Chronic, B-Cell 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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