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NCT02160015 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery
A Phase 1 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT02160015: Active Phase 1 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, sponsored by National Cancer Institute (NCI).
NCT02160015 is a Phase 1 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 49-participant average among 20 other Recurrent Chronic Lymphocytic Leukemia trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02160015, a Phase 1 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of lenalidomide when given together with ibrutinib and rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back (relapsed), has not responded well to prior treatments (refractory), has spread to other parts of the body (metastatic), or cannot be removed by surgery. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress 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 that may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide together with ibrutinib and rituximab may kill more cancer cells.
Primary Outcome
Graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- PROCEDURE Electrocardiogram
- DRUG Ibrutinib
Study Locations (2)
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
New Jersey
- Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-05-20 |
| Est. Completion | 2026-08-13 |
| Phase | Phase 1 |
What the registry record for NCT02160015 still lists
NCT02160015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 49-participant average among 20 other Recurrent Chronic Lymphocytic Leukemia trials with a reported enrollment target (76% lower).
The record links to 4 conditions, with Recurrent Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02160015 reports a single indexed study location in District of Columbia, New Jersey.
Frequently Asked Questions
What is clinical trial NCT02160015 about?
NCT02160015 is a clinical study titled "Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery". This phase I trial studies the side effects and best dose of lenalidomide when given together with ibrutinib and rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back (relapsed), has not responded well to prior treatments (refractory), has ...
What is the current status of trial NCT02160015?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2014-05-20. Estimated completion is 2026-08-13.
What conditions does trial NCT02160015 study?
This clinical trial studies the following conditions: Recurrent Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT02160015?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Electrocardiogram (PROCEDURE), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02160015?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02160015 being conducted?
This trial has 2 study locations across District of Columbia, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02160015's enrollment target sits among peer trials
12 20th of 20 higher than 1 of 20 other Recurrent Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Chronic Lymphocytic Leukemia 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.
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