Trial · NCT04624633

Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL

NCT04624633, Phase 2, Active not recruiting, Jennifer R. Brown, MD, PhD; results first posted 2025-02-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL. Trials, record NCT04624633. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04624633

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL
NCT number: NCT04624633
Status: Active not recruiting
Phases: Phase 2
Enrollment: 29 participants, actual
Lead sponsor: Jennifer R. Brown, MD, PhD
Conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
Interventions: Acalabrutinib, Umbralisib, Ublituximab
First posted: 2020-11-12
Last updated: 2026-02-25
Results first posted: 2025-02-27

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Complete Remission (CR) Rate After 24 Cycles	According to this endpoint is after 24 cycles. Overall median number of cycles is 24 with range 1-25.	The CR Rate is defined as the proportion of participants achieving complete remission (CR) based on 2018 IW-CLL criteria.
Secondary	Partial Remission (PR) Rate After 24 Cycles	According to this endpoint is after 24 cycles. Overall median number of cycles is 24 with range 1-25.	The PR Rate is defined as the proportion of participants achieving partial remission (PR) based on 2018 IW-CLL criteria.
Secondary	Median Progression-Free Survival (PFS)	Disease will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. Observation on treatment up to approximately 25 cycles. In long-term follow-up, survival follow-up up to 5 years.	Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last dsease assessment.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Complete Remission (CR) Rate After 24 Cycles	According to this endpoint is after 24 cycles. Overall median number of cycles is 24 with range 1-25.	Patients who completed 24 cycle of treatment.	proportion of participants	NUMBER
SECONDARY	Partial Remission (PR) Rate After 24 Cycles	According to this endpoint is after 24 cycles. Overall median number of cycles is 24 with range 1-25.		proportion of participants	NUMBER
SECONDARY	Median Progression-Free Survival (PFS)	Disease will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. Observation on treatment up to approximately 25 cycles. In long-term follow-up, survival follow-up up to 5 years.

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Complete Remission (CR) Rate After 24 Cycles	Cohort 1 - Relapsed Disease	0.33	95% Confidence Interval 0.043 to 0.777	proportion of participants
Complete Remission (CR) Rate After 24 Cycles	Cohort 2 - Treatment Naive	0.29	95% Confidence Interval 0.084 to 0.582	proportion of participants
Partial Remission (PR) Rate After 24 Cycles	Cohort 1 - Relapsed Disease	0.66	95% Confidence Interval 0.22 to 0.88	proportion of participants
Partial Remission (PR) Rate After 24 Cycles	Cohort 2 - Treatment Naive	0.57	95% Confidence Interval 0.29 to 0.77	proportion of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort 1 - Relapsed Disease	8
Overall Study	STARTED	Cohort 2 - Treatment Naive	21
Overall Study	COMPLETED	Cohort 1 - Relapsed Disease	7
Overall Study	COMPLETED	Cohort 2 - Treatment Naive	20
Overall Study	NOT COMPLETED	Cohort 1 - Relapsed Disease	1
Overall Study	NOT COMPLETED	Cohort 2 - Treatment Naive	1

Source ClinicalTrials.gov

Adverse events212

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Cohort 1 - Relapsed Disease	2	8
other	Anemia	Blood and lymphatic system disorders	Cohort 2 - Treatment Naive	0	21
other	Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	Cohort 1 - Relapsed Disease	0	8
other	Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	Cohort 2 - Treatment Naive	1	21
other	Lymph node pain	Blood and lymphatic system disorders	Cohort 1 - Relapsed Disease	0	8
other	Lymph node pain	Blood and lymphatic system disorders	Cohort 2 - Treatment Naive	2	21
other	Chest pain - cardiac	Cardiac disorders	Cohort 1 - Relapsed Disease	1	8
other	Chest pain - cardiac	Cardiac disorders	Cohort 2 - Treatment Naive	0	21
other	Sinus bradycardia	Cardiac disorders	Cohort 1 - Relapsed Disease	1	8
other	Sinus bradycardia	Cardiac disorders	Cohort 2 - Treatment Naive	2	21

1 to 10 of 212Source ClinicalTrials.gov

See all 212 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1 - Relapsed Disease	1	8
Total, all-cause mortality	Cohort 2 - Treatment Naive	0	21
Total, other adverse events	Cohort 1 - Relapsed Disease	8	8
Total, other adverse events	Cohort 2 - Treatment Naive	21	21
Total, serious adverse events	Cohort 1 - Relapsed Disease	7	8
Total, serious adverse events	Cohort 2 - Treatment Naive	16	21

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40085050	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Cohort 1 - Relapsed Disease vs Cohort 2 - Treatment Naive: deaths from any cause	Trial comparisons
Cohort 1 - Relapsed Disease vs Cohort 2 - Treatment Naive: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04624633

GET https://conductscience.org/api/trials/v1/NCT04624633/events?page=2

API reference For AI assistants