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NCT02113007 · ClinicalTrials.gov registry record · Phase 2
Study of High-Dose Rituximab With Temozolomide as Treatment for Primary Central Nervous System (CNS) Lymphoma
A Phase 2 study, sponsored by SCRI Development Innovations.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT02113007: Clinical Trial Phase 2 study, sponsored by SCRI Development Innovations.
NCT02113007 is a Phase 2 study that was terminated before completion, run by SCRI Development Innovations. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02113007, a Phase 2 study, was terminated before completion, sponsored by SCRI Development Innovations.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of high-dose rituximab combined with temozolomide in the treatment of patients with Primary Central Nervous System Lymphomas (PCNSL). This novel combination will be evaluated in PCNSL patients who are 60 years of age or older, or in patients 18 years or older who refuse methotrexate-based treatment.
Primary Outcome
Patients will be assessed for response by MRI of brain and/or spine after 4 cycles (8 weeks) of treatment according to Response Criteria for Primary CNS Lymphoma. Patients with stable disease or better (CR or PR) will continue treatment for 12 cycles (24 weeks). Complete Response (CR)=no contrast enhancement, normal eye exam. Partial Response (PR)=50 percent decrease in tumor enhancement, minor retinal pigment epithelium abnormality in eye exam. Stable disease (SD)= a change in lesion size that
Interventions
- DRUG Rituximab plus Temozolomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
Why NCT02113007 stopped before completion
NCT02113007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Rituximab plus Temozolomide is the first listed.
NCT02113007 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02113007 about?
NCT02113007 is a clinical study titled "Study of High-Dose Rituximab With Temozolomide as Treatment for Primary Central Nervous System (CNS) Lymphoma". This study will evaluate the safety and efficacy of high-dose rituximab combined with temozolomide in the treatment of patients with Primary Central Nervous System Lymphomas (PCNSL). This novel combination will be evaluated in PCNSL patients who are 60 years of age or older, or in patients 18 years ...
What is the current status of trial NCT02113007?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2014-07. Estimated completion is 2016-02.
What interventions are being tested in trial NCT02113007?
The interventions under investigation include: Rituximab plus Temozolomide (DRUG).
Who is sponsoring clinical trial NCT02113007?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02113007's enrollment target sits among peer trials
2 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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