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NCT01596127 · ClinicalTrials.gov registry record · Phase 1
Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01596127: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01596127 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01596127, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn about the safety and effectiveness of rituximab given by spinal tap in patients with lymphoid malignancies involving the central nervous system. A spinal tap (also called a lumbar puncture) is when fluid surrounding the spinal cord is collected by inserting a needle into the lower back. The affected area is numbed with local anesthetic during the procedure. It will also be used to give chemotherapy in this study. Rituximab is designed to bind to a protein, called CD20, that is on the surface of the leukemia cells. This may cause the leukemia cells to die.
Primary Outcome
The percentage of participants whose cancer shrinks or disappears after treatment where participants are considered as responding to therapy if the Cerebrospinal fluid (CSF) is without evidence of blast cells after four lumbar punctures with rituximab.
Interventions
- DRUG Intrathecal Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2013-01-24 |
| Est. Completion | 2017-03-23 |
| Phase | Phase 1 |
Why NCT01596127 stopped before completion
NCT01596127 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Intrathecal Rituximab is the first listed.
NCT01596127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01596127 about?
NCT01596127 is a clinical study titled "Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System". The goal of this clinical research study is to learn about the safety and effectiveness of rituximab given by spinal tap in patients with lymphoid malignancies involving the central nervous system. A spinal tap (also called a lumbar puncture) is when fluid surrounding the spinal cord is collected b...
What is the current status of trial NCT01596127?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2013-01-24. Estimated completion is 2017-03-23.
What interventions are being tested in trial NCT01596127?
The interventions under investigation include: Intrathecal Rituximab (DRUG).
Who is sponsoring clinical trial NCT01596127?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01596127's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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