Spots Global Cancer Trial Database for Ibrutinib and Lenalidomide in Treating Patients With Myelodysplastic Syndrome

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Trial Identification

Brief Title: Ibrutinib and Lenalidomide in Treating Patients With Myelodysplastic Syndrome

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

Study ID: NCT03359460

Conditions

Myelodysplastic Syndrome

Previously Treated Myelodysplastic Syndrome

Refractory High Risk Myelodysplastic Syndrome

Secondary Myelodysplastic Syndrome

Interventions

Ibrutinib

Lenalidomide

Study Description

Brief 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.