Trial · NCT04657094
Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia
NCT04657094, Phase 2, Active not recruiting, City of Hope Medical Center; results first posted 2024-05-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia. Trials, record NCT04657094. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04657094
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia
- NCT number
- NCT04657094
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Autoimmune Hemolytic Anemia, Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Warm Antibody Autoimmune Hemolytic Anemia
- Interventions
- Acalabrutinib
- First posted
- 2020-12-08
- Last updated
- 2026-05-06
- Results first posted
- 2024-05-29
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Autoimmune Hemolytic Anemia (AIHA) - Overall Response Rate (ORR) | Participants were assessed at the end of the 6-week therapy. | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Autoimmune Hemolytic Anemia (AIHA) - Overall Response Rate (ORR) | Participants were assessed at the end of the 6-week therapy. | Among the 4 enrolled participants, one was in-evaluable for not finishing 6 cycles of the study treatment due to toxicity. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Autoimmune Hemolytic Anemia (AIHA) - Overall Response Rate (ORR) | Treatment (Acalabrutinib) | 67 | 95% Confidence Interval 9 to 99 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Acalabrutinib) | 4 | |
| Overall Study | COMPLETED | Treatment (Acalabrutinib) | 4 | |
| Overall Study | NOT COMPLETED | Treatment (Acalabrutinib) | 0 |
Source ClinicalTrials.gov
Adverse events42
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 | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Acalabrutinib) | 1 | 4 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Acalabrutinib) | 1 | 4 | 1 |
| other | Dental Fractures | Gastrointestinal disorders | Treatment (Acalabrutinib) | 1 | 4 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Acalabrutinib) | 1 | 4 | 1 |
| other | Gastroesophageal reflux disease | Gastrointestinal disorders | Treatment (Acalabrutinib) | 1 | 4 | 1 |
| other | Mucositis oral | Gastrointestinal disorders | Treatment (Acalabrutinib) | 1 | 4 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment (Acalabrutinib) | 1 | 4 | 1 |
| other | Vomiting | Gastrointestinal disorders | Treatment (Acalabrutinib) | 1 | 4 | 1 |
| other | Edema limbs | General disorders | Treatment (Acalabrutinib) | 1 | 4 | 1 |
| other | Fatigue | General disorders | Treatment (Acalabrutinib) | 3 | 4 | 3 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Acalabrutinib) | 0 | 4 |
| Total, other adverse events | Treatment (Acalabrutinib) | 4 | 4 |
| Total, serious adverse events | Treatment (Acalabrutinib) | 2 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT04657094
GET https://conductscience.org/api/trials/v1/NCT04657094/events?page=2