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NCT03788291 · ClinicalTrials.gov registry record · Phase 2
Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
A Phase 2 study of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT03788291: Completed Phase 2 study of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), sponsored by University of Rochester.
NCT03788291 is a Phase 2 study of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) that has completed, run by University of Rochester. The registered enrollment target is 39 participants, below the 190-participant average among 29 other Chronic Lymphocytic Leukemia (CLL) trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03788291, a Phase 2 study of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this research study is to find out if the combination of acalabrutinib and high frequency low dose subcutaneous rituximab is safe and effective in patients who have previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Primary Outcome
To satisfy criteria for a CR, all of the following criteria must be met: * No evidence of new disease * ALC in peripheral blood of \<4 x 109/L * Regression of all target nodal masses to normal size ≤1.5 cm in the LD * Normal spleen and liver size * Regression to normal of all nodal non-target disease and disappearance of all detectable non-nodal, non-target disease * Morphologically negative bone marrow defined as \<30% of nucleated cells being lymphoid cells and no lymphoid nodules in a bone m
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Acalabrutinib
Study Locations (1)
New York
- University of Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-03-25 |
| Est. Completion | 2023-05-19 |
| Phase | Phase 2 |
What the finished NCT03788291 record still lists
NCT03788291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 190-participant average among 29 other Chronic Lymphocytic Leukemia (CLL) trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Chronic Lymphocytic Leukemia (CLL) appearing as the primary indexed condition, and to 2 interventions - of which Rituximab is the first listed.
NCT03788291 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03788291 about?
NCT03788291 is a clinical study titled "Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma". The main purpose of this research study is to find out if the combination of acalabrutinib and high frequency low dose subcutaneous rituximab is safe and effective in patients who have previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
What is the current status of trial NCT03788291?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2019-03-25. Estimated completion is 2023-05-19.
What conditions does trial NCT03788291 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL).
What interventions are being tested in trial NCT03788291?
The interventions under investigation include: Rituximab (DRUG), Acalabrutinib (DRUG).
Who is sponsoring clinical trial NCT03788291?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03788291 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
Similar trials for Chronic Lymphocytic Leukemia (CLL)
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 NCT03788291's enrollment target sits among peer trials
39 20th of 29 higher than 8 of 29 other Chronic Lymphocytic Leukemia (CLL) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia (CLL) 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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Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)
RECRUITING · Phase 2
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A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201)
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Zanubrutinib and Venetoclax in CLL (ZANU-VEN)
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Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)
RECRUITING · Phase 2
-
The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL)
ACTIVE NOT RECRUITING · Phase 2
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Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax
ACTIVE NOT RECRUITING · Phase 2
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