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NCT01807598 · ClinicalTrials.gov registry record · Phase 2
Brentuximab Vedotin in Treating Patients With Advanced Systemic Mastocytosis or Mast Cell Leukemia
A Phase 2 study of Systemic Mastocytosis and Aggressive Systemic Mastocytosis, sponsored by Jason Robert Gotlib.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT01807598: Completed Phase 2 study of Systemic Mastocytosis and Aggressive Systemic Mastocytosis, sponsored by Jason Robert Gotlib.
NCT01807598 is a Phase 2 study of Systemic Mastocytosis and Aggressive Systemic Mastocytosis that has completed, run by Jason Robert Gotlib. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01807598, a Phase 2 study of Systemic Mastocytosis and Aggressive Systemic Mastocytosis, has completed, sponsored by Jason Robert Gotlib.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
This pilot clinical trial studies brentuximab vedotin in treating patients with advanced systemic mastocytosis or mast cell leukemia. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them
Primary Outcome
Overall response rate (ORR) is sum of complete response (CR); partial response (PR); and clinical improvement (CI) in 1 year, ie, ORR=CR+PR+CI. The outcome is the number of participants without dispersion. CR is following with response duration(RD) ≥12 weeks (wk) * No mast cell disease * Tryptase \<20 ng/mL * Neutrophils ≥1x10e9/L with normal differential * Hemoglobin ≥11 g/dL * Platelets ≥100x10e9/L * No hepatosplenomegaly * No systemic mastocytosis(SM)-related organ damage PR is following wi
Conditions Studied
Interventions
- DRUG Brentuximab vedotin
Study Locations (2)
California
- Stanford University, School of Medicine - Stanford
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-09 |
| Phase | Phase 2 |
What the finished NCT01807598 record still lists
NCT01807598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Systemic Mastocytosis appearing as the primary indexed condition, and to 1 intervention - of which Brentuximab vedotin is the first listed.
NCT01807598 reports a single indexed study location in California, Texas.
Frequently Asked Questions
What is clinical trial NCT01807598 about?
NCT01807598 is a clinical study titled "Brentuximab Vedotin in Treating Patients With Advanced Systemic Mastocytosis or Mast Cell Leukemia". This pilot clinical trial studies brentuximab vedotin in treating patients with advanced systemic mastocytosis or mast cell leukemia. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find ...
What is the current status of trial NCT01807598?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2013-09. Estimated completion is 2017-09.
What conditions does trial NCT01807598 study?
This clinical trial studies the following conditions: Systemic Mastocytosis, Aggressive Systemic Mastocytosis, Mast Cell Leukemia.
What interventions are being tested in trial NCT01807598?
The interventions under investigation include: Brentuximab vedotin (DRUG).
Who is sponsoring clinical trial NCT01807598?
This trial is sponsored by Jason Robert Gotlib, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01807598 being conducted?
This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01807598's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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