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About
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.
Full 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.
Enrollment
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Volunteers
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
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
Ability to understand and willingness to sign an informed consent form
Ability to adhere to the study visit schedule and other protocol requirements
Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for >= 1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy); or, female subjects of childbearing potential must have a negative serum pregnancy test upon study entry
Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategies (REMS) program
All study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of the REMS program
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of ibrutinib or ability to adhere to the Revlimid REMS program will be determined following review of their case by the principal investigator
Exclusion criteria
Primary purpose
Allocation
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4 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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