Trials / Active Not Recruiting
Active Not RecruitingNCT04657094
Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia
A Phase 2 Trial of Acalabrutinib for the Treatment of Relapsed/Refractory Autoimmune Hemolytic Anemia
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Autoimmune Hemolytic Anemia
- Chronic Lymphocytic Leukemia
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Warm Antibody Autoimmune Hemolytic Anemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acalabrutinib | Given PO |
Timeline
- Start date
- 2021-03-16
- Primary completion
- 2023-04-01
- Completion
- 2026-02-27
- First posted
- 2020-12-08
- Last updated
- 2025-04-27
- Results posted
- 2024-05-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04657094. Inclusion in this directory is not an endorsement.