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NCT02415608 · ClinicalTrials.gov registry record · Phase 2
Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis
A Phase 2 study, sponsored by Jason Robert Gotlib.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT02415608: Clinical Trial Phase 2 study, sponsored by Jason Robert Gotlib.
NCT02415608 is a Phase 2 study that was terminated before completion, run by Jason Robert Gotlib. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02415608, a Phase 2 study, was terminated before completion, sponsored by Jason Robert Gotlib.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
Overall response rate (ORR) is reported as the sum of the rates of participants achieving complete remission (CR), partial remission (PR), \& clinical improvement (CI). A clinical response is a response with duration of ≥ 12 weeks. CR is defined as all 4 criteria: * No presence of compact neoplastic mast cell aggregates * Serum tryptase level \< 20 ng/mL * Peripheral blood count remission defined as absolute neutrophil count (ANC) ≥1 x 10e9/L + normal differential, Hb ≥11 g/dL, \& platelet cou
Interventions
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2015-03 |
| Est. Completion | 2017-06-14 |
| Phase | Phase 2 |
Why NCT02415608 stopped before completion
NCT02415608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Ibrutinib is the first listed.
NCT02415608 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02415608 about?
NCT02415608 is a clinical study titled "Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis". 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 ma...
What is the current status of trial NCT02415608?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2015-03. Estimated completion is 2017-06-14.
What interventions are being tested in trial NCT02415608?
The interventions under investigation include: Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02415608?
This trial is sponsored by Jason Robert Gotlib, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02415608's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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