NCT03267186

Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant

A Phase 2 Study of Ibrutinib Maintenance After Reduced-Intensity Conditioning and Allogeneic Hematopoietic Cell Transplantation for Acute Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Andrew Rezvani · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well ibrutinib works in preventing acute leukemia in patients after reduced-intensity conditioning and stem cell transplant. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To reduce the incidence of relapse at 18 months after reduced-intensity conditioning (RIC) and allogeneic hematopoietic cell transplantation (HCT) for acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and chronic myeloid leukemia (CML) in blast crisis from a historical baseline of 45% to 25%, using ibrutinib maintenance therapy. SECONDARY OBJECTIVES: I. To study the incidence and severity of post-transplant complications in subjects receiving ibrutinib maintenance after allogeneic HCT. II. To study the incidence of infectious complications in subjects receiving maintenance ibrutinib after allogeneic HCT. III. To study the impact of ibrutinib maintenance on minimal residual disease after RIC and allogeneic HCT. IV. To study the impact of maintenance ibrutinib on immune reconstitution and alloreactivity after allogeneic HCT, specifically on Th1/ Th2 polarization, T follicular cell number, T and B cell repertoire, serum immunoglobulin levels, and alloantibody formation. OUTLINE: Beginning 60-90 days after allogeneic HCT, patients receive ibrutinib orally (PO) once daily (QD) for up to 18 months post-transplant in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.

Conditions

• Acute Biphenotypic Leukemia
• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Hematopoietic Cell Transplantation Recipient

Interventions

Type	Name	Description
DRUG	Ibrutinib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-09-12
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2017-08-30
• Last updated: 2023-08-01
• Results posted: 2023-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study