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NCT01829568 · ClinicalTrials.gov registry record · Phase 1
Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma
A Phase 1 study of Ann Arbor Stage III Grade 2 Follicular Lymphoma and Ann Arbor Stage III Grade 3 Follicular Lymphoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 7
- Study locations
NCT01829568: Active Phase 1 study of Ann Arbor Stage III Grade 2 Follicular Lymphoma and Ann Arbor Stage III Grade 3 Follicular Lymphoma, sponsored by National Cancer Institute (NCI).
NCT01829568 is a Phase 1 study of Ann Arbor Stage III Grade 2 Follicular Lymphoma and Ann Arbor Stage III Grade 3 Follicular Lymphoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 33 participants, below the 58-participant average among 3 other Ann Arbor Stage III Grade 2 Follicular Lymphoma trials with a reported enrollment target (43% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01829568, a Phase 1 study of Ann Arbor Stage III Grade 2 Follicular Lymphoma and Ann Arbor Stage III Grade 3 Follicular Lymphoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 7
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of lenalidomide and ibrutinib when given together with rituximab in treating patients with previously untreated stage II-IV follicular lymphoma. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving lenalidomide and ibrutinib together with rituximab may work well in treating follicular lymphoma.
Primary Outcome
Defined as the highest dose at which 0 or 1 of 6 patients experience DLT. Will be determined by dose-limiting toxicities (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Conditions Studied
Interventions
- DRUG Lenalidomide
- BIOLOGICAL Rituximab
- DRUG Ibrutinib
Study Locations (7)
New York
- Roswell Park Cancer Institute - Buffalo
- NYP/Weill Cornell Medical Center - New York
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Massachusetts
- Dana-Farber Cancer Institute - Boston
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-06-26 |
| Est. Completion | 2026-06-06 |
| Phase | Phase 1 |
What the registry record for NCT01829568 still lists
NCT01829568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 58-participant average among 3 other Ann Arbor Stage III Grade 2 Follicular Lymphoma trials with a reported enrollment target (43% lower).
The record links to 10 conditions, with Ann Arbor Stage III Grade 2 Follicular Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Lenalidomide is the first listed.
NCT01829568 lists 7 locations in 6 states (New York, District of Columbia, Illinois).
Frequently Asked Questions
What is clinical trial NCT01829568 about?
NCT01829568 is a clinical study titled "Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma". This phase I trial studies the side effects and best dose of lenalidomide and ibrutinib when given together with rituximab in treating patients with previously untreated stage II-IV follicular lymphoma. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing...
What is the current status of trial NCT01829568?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2013-06-26. Estimated completion is 2026-06-06.
What conditions does trial NCT01829568 study?
This clinical trial studies the following conditions: Ann Arbor Stage III Grade 2 Follicular Lymphoma, Ann Arbor Stage III Grade 3 Follicular Lymphoma, Ann Arbor Stage IV Grade 1 Follicular Lymphoma, Ann Arbor Stage III Grade 1 Follicular Lymphoma, Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma.
What interventions are being tested in trial NCT01829568?
The interventions under investigation include: Lenalidomide (DRUG), Rituximab (BIOLOGICAL), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT01829568?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01829568 being conducted?
This trial has 7 study locations across District of Columbia, Illinois, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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