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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 is a Phase 2 study that has completed, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 289 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01216683
The ClinicalTrials.gov registry entry for NCT01216683 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 289 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which rituximab is the first listed.
NCT01216683 reports 0 study locations.
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.
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