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NCT01235793 · ClinicalTrials.gov registry record · Phase 2
The Addition of Temozolomide to Conditioning for Autologous Transplantation in Relapsed & Refractory CNS Lymphoma
A Phase 2 study, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01235793: Clinical Trial Phase 2 study, sponsored by Cedars-Sinai Medical Center.
NCT01235793 is a Phase 2 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01235793, a Phase 2 study, was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The primary purpose of the study will be testing the dosing of temozolomide to find the target dose that a person can tolerate. The other part of the study will be determining how helpful it can be to CNS lymphoma patients by adding temozolomide to the "conditioning regimen" prior to stem cell transplantation. This research study is designed to test the investigational use of temozolomide as part of a conditioning regimen prior to stem cell transplantation. This drug has not yet been approved by the U.S. Food and Drug Administration (FDA) to be used in the setting of stem cell transplantation in lymphomas of the brain (central nervous system or CNS) but it has been studied and used before in transplantation with reasonable results.
Primary Outcome
Efficacy of the DRBEAT Regimen will be assessed by analysis of 1. one-year progression-free survival (PFS), defined as the time interval from maximal response from therapy to tumor regrowth, progression\*, or death, (\*Progression is defined as meeting the response criteria listed in Table 4: Response Criteria for Primary Central Nervous System Lymphoma according to Abrey LE, Batchelor TT, Ferreri AJM et al.) and 2. Overall survival, defined as the time interval between the date of transpla
Interventions
- DRUG Temozolomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-10-14 |
| Est. Completion | 2018-04-18 |
| Phase | Phase 2 |
Why NCT01235793 stopped before completion
NCT01235793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 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 0 conditions, and to 1 intervention - of which Temozolomide is the first listed.
NCT01235793 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01235793 about?
NCT01235793 is a clinical study titled "The Addition of Temozolomide to Conditioning for Autologous Transplantation in Relapsed & Refractory CNS Lymphoma". The primary purpose of the study will be testing the dosing of temozolomide to find the target dose that a person can tolerate. The other part of the study will be determining how helpful it can be to CNS lymphoma patients by adding temozolomide to the "conditioning regimen" prior to stem cell trans...
What is the current status of trial NCT01235793?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2010-10-14. Estimated completion is 2018-04-18.
What interventions are being tested in trial NCT01235793?
The interventions under investigation include: Temozolomide (DRUG).
Who is sponsoring clinical trial NCT01235793?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01235793's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 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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