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NCT05388006 · ClinicalTrials.gov registry record · Phase 2

Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Mayo Clinic.

Recruiting
Registry status
Phase 2
Development phase
27
Enrollment target
3
Study locations

NCT05388006: Recruiting Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Mayo Clinic.

NCT05388006 is a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 27 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (85% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05388006, a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
Phase 2
Development phase
27 participants
Enrollment target
3
Study locations

Study Summary

This phase II trial tests whether acalabrutinib, venetoclax, and durvalumab work in treating patients with Richter transformation from chronic lymphocytic leukemia or small lymphocytic lymphoma. Richter transformation is a rare condition in which chronic lymphocytic leukemia or small lymphocytic lymphoma changes into a fast-growing type of lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib, venetoclax, and durvalumab may help improve survival in patients with Richter transformation.

Primary Outcome

Progression will be defined by Lugano positron emission tomography (PET)-computed tomography (CT) based criteria or chronic lymphocytic leukemia (CLL) criteria. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If patients are censored prior to 6 months, a Kaplan Meier estimate for pro

Conditions Studied

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Richter Syndrome

Interventions

  • DRUG Venetoclax
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • BIOLOGICAL Durvalumab
  • DRUG Acalabrutinib

Study Locations (3)

California

  • Stanford Cancer Institute Palo Alto - Palo Alto

Minnesota

  • Mayo Clinic in Rochester - Rochester

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2023-01-05
Est. Completion 2027-02-22
Phase Phase 2
Mayo Clinic

2,844 total trials

What NCT05388006 shows while recruiting

NCT05388006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (85% lower).

The record links to 3 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.

NCT05388006 reports a single indexed study location in California, Minnesota, Missouri.

Frequently Asked Questions

What is clinical trial NCT05388006 about?

NCT05388006 is a clinical study titled "Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". This phase II trial tests whether acalabrutinib, venetoclax, and durvalumab work in treating patients with Richter transformation from chronic lymphocytic leukemia or small lymphocytic lymphoma. Richter transformation is a rare condition in which chronic lymphocytic leukemia or small lymphocytic lym...

What is the current status of trial NCT05388006?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2023-01-05. Estimated completion is 2027-02-22.

What conditions does trial NCT05388006 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter Syndrome.

What interventions are being tested in trial NCT05388006?

The interventions under investigation include: Venetoclax (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Durvalumab (BIOLOGICAL), Acalabrutinib (DRUG).

Who is sponsoring clinical trial NCT05388006?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05388006 being conducted?

This trial has 3 study locations across California, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for 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 NCT05388006's enrollment target sits among peer trials

27 142nd of 187 higher than 42 of 187 other Chronic Lymphocytic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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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More recruiting context for NCT05388006

Source: ClinicalTrials.gov NCT05388006, the US trial registry maintained by the National Library of Medicine. NCT05388006 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.