Ibrutinib and Lenalidomide in Treating Patients With Myelodysplastic Syndrome (NCT03359460) | Clinical Trial Compass
CompletedPhase 1
Ibrutinib and Lenalidomide in Treating Patients With Myelodysplastic Syndrome
United States4 participantsStarted 2017-12-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Pathologically confirmed diagnosis of MDS by World Health Organization (WHO) criteria (including secondary and therapy-related disease) who have failed standard therapy, who are intolerant of prior therapy, or who refuse standard therapy; any prior therapy, including ibrutinib and/or lenalidomide (unless intolerant of one or both of these medications), is permitted
* Hypomethylating agent failure is defined as disease progression or stable disease as best response to an adequate course of treatment (at least four cycles) with an injectable hypomethylating agent (azacitidine or decitabine)
* International Prognostic Scoring System (IPSS)-revised (R) intermediate, high or very high risk disease
* No specific hematologic parameters for study entry are required; transfusion-dependent patients are eligible and platelet counts should be maintained greater than 10,000/mm\^3
* Serum aspartate transaminase (AST) or alanine transaminase (ALT) less than or equal to 3.0 x upper limit of normal (ULN)
* Estimated creatinine clearance greater than or equal to 60 ml/min (Cockcroft-Gault)
* Bilirubin less than or equal to 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
* Prothrombin time (PT)/international normalized ratio (INR) less than or equal to 1.5 x ULN and partial thromboplastin time (PTT) (activated \[a\]PTT) less than or equal to 1.5 x ULN
* Karnofsky performance status (KPS) performance status of 60% or greater
* Abi…