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NCT01197560 · ClinicalTrials.gov registry record · Phase 2
Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 111
- Enrollment target
NCT01197560: Completed Phase 2 study, sponsored by Celgene.
NCT01197560 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 111 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01197560, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 111 participants
- Enrollment target
Study Summary
The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.
Primary Outcome
An overall response is a complete response (CR), unconfirmed complete response (CRu) or partial response (PR) and was evaluated by the IRAC. A CR = complete disappearance of disease and related symptoms. Lymph nodes and nodal masses regressed on computed tomography to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and \> 1.0 cm in their short axis prior to therapy). Spleen a
Interventions
- DRUG Oxaliplatin
- DRUG Rituximab
- DRUG Etoposide
- DRUG Lenalidomide
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2010-09-02 |
| Est. Completion | 2018-04-05 |
| Phase | Phase 2 |
What the finished NCT01197560 record still lists
NCT01197560 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 5 interventions - of which Oxaliplatin is the first listed.
NCT01197560 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01197560 about?
NCT01197560 is a clinical study titled "Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)". The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.
What is the current status of trial NCT01197560?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2010-09-02. Estimated completion is 2018-04-05.
What interventions are being tested in trial NCT01197560?
The interventions under investigation include: Oxaliplatin (DRUG), Rituximab (DRUG), Etoposide (DRUG), Lenalidomide (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT01197560?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01197560's enrollment target sits among peer trials
111 632nd of 2000 higher than 1,369 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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