Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis (NCT02415608) | Clinical Trial Compass
TerminatedPhase 2
Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis
Stopped: Slow accrual
United States4 participantsStarted 2015-03
Plain-language summary
This phase 2 trial studies ibrutinib to see how well it works in treating patients with systemic (affecting the entire body) mastocytosis that has spread to other parts of the body and usually cannot be cured or controlled with treatment (advanced). Systemic mastocytosis is a disease in which too many mast cells (a type of immune system cell) are found throughout the body. Mast cells give off chemicals such as histamine that can cause flushing (a hot, red face), itching, abdominal cramps, muscle pain, nausea, vomiting, diarrhea, low blood pressure, and shock. Ibrutinib may stop the growth of mast cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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INCLUSION CRITERIA
* Diagnosis of systemic mastocytosis per 2008 World Health Organization (WHO) criteria. Those with advanced systemic mastocytosis (ASM); mast cell leukemia (MCL); or systemic mastocytosis-associated hematological clonal non-mast cell lineage disease (SM-AHNMD) required to have at least 1 organ damage finding
* Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN); if considered related to ASM/MCL ≤ 5 x ULN
* Estimated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault)
* Total bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin); if considered related to ASM/MCL ≤ 3 x ULN
* Female subjects must be of non-reproductive potential, or if of childbearing potential must have a negative serum pregnancy test upon study entry
* Must agree to use highly effective methods of birth control
* Written informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
* Life expectancy \> 12 weeks
EXCLUSION CRITERIA
* Received any investigational agent, chemotherapy, interferon-alpha, or 2-chlorodeoxyadenosine (2-CdA, cladribine) within 30 days prior to day 1; or monoclonal antibody ≤ 6 weeks prior to first administration of study treatment (patients with an AHNMD with progressive leukocytosis who require control of their counts are permitted to receive hydroxyurea)
* Diagnosis of AHNMD requiring immediate cytoreductive therapy or targeted drugs (eg, acut…