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NCT01216683 · ClinicalTrials.gov registry record · Phase 2
Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma
A Phase 2 study, sponsored by ECOG-ACRIN Cancer Research Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 289
- Enrollment target
NCT01216683: Completed Phase 2 study, sponsored by ECOG-ACRIN Cancer Research Group.
NCT01216683 is a Phase 2 study that has completed, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 289 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (117% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01216683, a Phase 2 study, has completed, sponsored by ECOG-ACRIN Cancer Research Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 289 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bendamustine hydrochloride and rituximab together alone is more effective than giving bendamustine hydrochloride and rituximab together with bortezomib or lenalidomide in treating follicular lymphoma. PURPOSE: This randomized phase II trial is studying giving bendamustine hydrochloride and rituximab together with or without bortezomib followed by rituximab with or without lenalidomide to see how well they work in treating patients with high-risk stage II, stage III, or stage IV follicular lymphoma.
Primary Outcome
Complete remission is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. This analysis was conducted among 222 evaluable patients for the primary analysis. The purpose of this analysis is to compare the complete remission rate of rituximab + bendamustine vs. bortezomib + rituximab + bendamustine as induction therapy, therefore, the proportion of patients with complete remission was compared between Arm B (bo
Interventions
- BIOLOGICAL rituximab
- DRUG lenalidomide
- DRUG bortezomib
- DRUG Bendamustin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2011-02-09 |
| Est. Completion | 2019-12-02 |
| Phase | Phase 2 |
What the finished NCT01216683 record still lists
NCT01216683 is an interventional study that assigns participants to a tested intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (117% higher).
The record links to 0 conditions, and to 4 interventions - of which rituximab is the first listed.
NCT01216683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01216683 about?
NCT01216683 is a clinical study titled "Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma". RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the abi...
What is the current status of trial NCT01216683?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 289 participants. The study started on 2011-02-09. Estimated completion is 2019-12-02.
What interventions are being tested in trial NCT01216683?
The interventions under investigation include: rituximab (BIOLOGICAL), lenalidomide (DRUG), bortezomib (DRUG), Bendamustin (DRUG).
Who is sponsoring clinical trial NCT01216683?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01216683's enrollment target sits among peer trials
289 191st of 2000 higher than 1,810 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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