Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT04657094
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2020-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
A Phase 2 Trial of Acalabrutinib for the Treatment of Relapsed/Refractory Autoimmune Hemolytic Anemia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
PRIMARY OBJECTIVE:
I. Assess the efficacy of acalabrutinib in chronic lymphocytic leukemia (CLL) patients with relapsed or refractory autoimmune hemolytic anemia (AIHA).
SECONDARY OBJECTIVES:
I. Evaluate acalabrutinib's ability to induce short term and sustained hemoglobin response.
II. Assess the toxicity of acalabrutinib. III. Evaluate efficacy of acalabrutinib in CLL.
EXPLORATORY OBJECTIVE:
I. Assess the effect of acalabrutinib on T-cell functionality in an autoimmune disorder.
OUTLINE:
Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Treatment with acalabrutinib may be continued beyond 12 cycles for a maximum of 36 cycles if, in the opinion of the treating physician, the patient might benefit from ongoing therapy.
After completion of study treatment, patients are followed up at 30 days and at least every 4 months for up to 12 months.
I. Assess the efficacy of acalabrutinib in chronic lymphocytic leukemia (CLL) patients with relapsed or refractory autoimmune hemolytic anemia (AIHA).
SECONDARY OBJECTIVES:
I. Evaluate acalabrutinib's ability to induce short term and sustained hemoglobin response.
II. Assess the toxicity of acalabrutinib. III. Evaluate efficacy of acalabrutinib in CLL.
EXPLORATORY OBJECTIVE:
I. Assess the effect of acalabrutinib on T-cell functionality in an autoimmune disorder.
OUTLINE:
Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Treatment with acalabrutinib may be continued beyond 12 cycles for a maximum of 36 cycles if, in the opinion of the treating physician, the patient might benefit from ongoing therapy.
After completion of study treatment, patients are followed up at 30 days and at least every 4 months for up to 12 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-10529 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 20311 | OTHER | City of Hope Comprehensive Cancer Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |