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NCT01316523 · ClinicalTrials.gov registry record · Phase 2
Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma
A Phase 2 study, sponsored by University of California, Davis.
- Terminated
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01316523: Clinical Trial Phase 2 study, sponsored by University of California, Davis.
NCT01316523 is a Phase 2 study that was terminated before completion, run by University of California, Davis. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01316523, a Phase 2 study, was terminated before completion, sponsored by University of California, Davis.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Lenalidomide has been shown to have single agent activity in indolent Non-Hodgkin's Lymphoma. It is approved for the treatment of multiple myeloma and myelodysplastic syndrome. Rituximab is effective as a single agent and in combination with chemotherapy for indolent Non-Hodgkin's Lymphoma. The purpose of this study is to see how well giving lenalidomide together with rituximab works in treating patients with previously untreated indolent Non Hodgkin's Lymphoma. Lenalidomide will taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, unacceptable side effects or after twelve cycles if the patient is responding well. Rituximab 375 mg/m2/wk x 4 weeks will begin on Day 15 of cycle 1. After 4 cycles of therapy, if patients respond well to treatment, patients will receive a second course of Rituximab. Blood samples will be collected to assess how the immune system is functioning.
Primary Outcome
Responses will be assessed by the Revised Working Group Response Criteria for Malignant Lymphoma. A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease. Response Rate defined as the proportion of patients whose best respo
Interventions
- DRUG Rituximab
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-12 |
| Est. Completion | 2024-04-14 |
| Phase | Phase 2 |
Why NCT01316523 stopped before completion
NCT01316523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT01316523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01316523 about?
NCT01316523 is a clinical study titled "Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma". Lenalidomide has been shown to have single agent activity in indolent Non-Hodgkin's Lymphoma. It is approved for the treatment of multiple myeloma and myelodysplastic syndrome. Rituximab is effective as a single agent and in combination with chemotherapy for indolent Non-Hodgkin's Lymphoma. The pu...
What is the current status of trial NCT01316523?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2010-12. Estimated completion is 2024-04-14.
What interventions are being tested in trial NCT01316523?
The interventions under investigation include: Rituximab (DRUG), Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT01316523?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01316523's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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