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NCT04657094 · ClinicalTrials.gov registry record · Phase 2

Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia

A Phase 2 study of Chronic Lymphocytic Leukemia and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, sponsored by City of Hope Medical Center.

Active
Registry status
Phase 2
Development phase
4
Enrollment target
1
Study location

NCT04657094: Active Phase 2 study of Chronic Lymphocytic Leukemia and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, sponsored by City of Hope Medical Center.

NCT04657094 is a Phase 2 study of Chronic Lymphocytic Leukemia and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 4 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04657094, a Phase 2 study of Chronic Lymphocytic Leukemia and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
4 participants
Enrollment target
1
Study location

Study Summary

This phase II trial studies the effect of acalabrutinib in treating autoimmune hemolytic anemia that has come back (relapsed) or has not responded to previous treatment (refractory) in patients with chronic lymphocytic leukemia. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Primary Outcome

ORR is defined as proportion of patients who achieve complete response (CR) and partial response (PR). The probability of having AIHA-ORR at 6 cycles were measured and reported with 95% exact confidence interval (CI). An exact binomial test against a null hypothesis of 30% rate was performed at the 1-sided alpha of 0.05 to determine whether the AIHA-ORR rate at 6 cycles is disappointing or promising.

Conditions Studied

Chronic Lymphocytic Leukemia Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Warm Antibody Autoimmune Hemolytic Anemia Autoimmune Hemolytic Anemia

Interventions

  • DRUG Acalabrutinib

Study Locations (1)

California

  • City of Hope Medical Center - Duarte

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2021-03-16
Est. Completion 2026-02-27
Phase Phase 2
City of Hope Medical Center

582 total trials

What the registry record for NCT04657094 still lists

NCT04657094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (98% lower).

The record links to 4 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Acalabrutinib is the first listed.

NCT04657094 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT04657094 about?

NCT04657094 is a clinical study titled "Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia". This phase II trial studies the effect of acalabrutinib in treating autoimmune hemolytic anemia that has come back (relapsed) or has not responded to previous treatment (refractory) in patients with chronic lymphocytic leukemia. Acalabrutinib may stop the growth of cancer cells by blocking some of t...

What is the current status of trial NCT04657094?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2021-03-16. Estimated completion is 2026-02-27.

What conditions does trial NCT04657094 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Warm Antibody Autoimmune Hemolytic Anemia, Autoimmune Hemolytic Anemia.

What interventions are being tested in trial NCT04657094?

The interventions under investigation include: Acalabrutinib (DRUG).

Who is sponsoring clinical trial NCT04657094?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04657094 being conducted?

This trial has 1 study location across California. 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 NCT04657094's enrollment target sits among peer trials

4 187th of 187 the lowest 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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Related registry views

Source: ClinicalTrials.gov NCT04657094, the US trial registry maintained by the National Library of Medicine. NCT04657094 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.