Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis

Part of paid clinical trials in Stanford, California.

Sponsor
Jason Robert Gotlib
Study ID
NCT02415608
Phase
PHASE2
Status
Terminated

Conditions

  • Aggressive Systemic Mastocytosis
  • Mast Cell Leukemia
  • Systemic Mastocytosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Given orally in 28-day cycles

Study Details

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.

Key Dates

Start date
Mar 31, 2015
Status verified
Aug 2018
Primary completion
Nov 4, 2016
Completion
Jun 14, 2017

Study Design

Enrollment
4 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib 420 mg/day
    Participants receive ibrutinib daily on days 1 to 28, at 420 mg/day in 28-day cycles
  • Experimental: Ibrutinib 560 mg/day
    Participants receive ibrutinib daily on days 1 to 28, at 560 mg/day in 28-day cycles

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Hospitals and ClinicsStanfordCalifornia94305-

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Stanford University Hospitals and Clinics· Stanford, CA

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