NCT03359460

Ibrutinib and Lenalidomide in Treating Patients With Myelodysplastic Syndrome

Phase I Trial of the Combination of Ibrutinib and Lenalidomide for the Treatment of Patients With MDS Who Have Failed or Refuse Standard Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of ibrutinib when giving together with lenalidomide in treating patients with myelodysplastic syndrome. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and lenalidomide may work better in treating patients with myelodysplastic syndrome.

Detailed description

PRIMARY OBJECTIVES: To determine the recommended Phase II dose (RP2D) for ibrutinib in combination with lenalidomide in patients with myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: To do an early assessment of the activity of the combination of ibrutinib and lenalidomide in patients with MDS. TERTIARY OBJECTIVES: To examine the pharmacodynamic and biological effects of the combination of ibrutinib and lenalidomide in MDS.

Conditions

• Myelodysplastic Syndrome
• Previously Treated Myelodysplastic Syndrome
• Refractory High Risk Myelodysplastic Syndrome
• Secondary Myelodysplastic Syndrome
• Therapy-Related Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Ibrutinib	Given PO
DRUG	Lenalidomide	Given PO

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-08-29
• Completion: 2019-11-17
• First posted: 2017-12-02
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study