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NCT04458610 · ClinicalTrials.gov registry record · Phase 2
Zanubrutinib and Rituximab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 2 study of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04458610: Active Phase 2 study of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, sponsored by M.D. Anderson Cancer Center.
NCT04458610 is a Phase 2 study of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 60 participants, above the 43-participant average among 7 other Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma trials with a reported enrollment target (40% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04458610, a Phase 2 study of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well zanubrutinib and rituximab work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma for which the patient has not received treatment in the past (previously untreated). Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The study is being done to find out if zanubrutinib combined with rituximab can help control previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
Primary Outcome
Will estimate the proportion of patients who have treatment-free remission 6 months after discontinuation of zanubrutinib. Success rate will be estimated with 95% credible interval and confidence interval.
Conditions Studied
Interventions
- DRUG Zanubrutinib
- BIOLOGICAL Rituximab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-05-26 |
| Est. Completion | 2026-05-26 |
| Phase | Phase 2 |
What the registry record for NCT04458610 still lists
NCT04458610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 43-participant average among 7 other Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma trials with a reported enrollment target (40% higher).
The record links to 1 condition, with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Zanubrutinib is the first listed.
NCT04458610 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04458610 about?
NCT04458610 is a clinical study titled "Zanubrutinib and Rituximab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". This phase II trial studies how well zanubrutinib and rituximab work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma for which the patient has not received treatment in the past (previously untreated). Zanubrutinib may stop the growth of cancer cells by blocking ...
What is the current status of trial NCT04458610?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2020-05-26. Estimated completion is 2026-05-26.
What conditions does trial NCT04458610 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT04458610?
The interventions under investigation include: Zanubrutinib (DRUG), Rituximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04458610?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04458610 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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