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NCT01515176 · ClinicalTrials.gov registry record · Phase 1
Ofatumumab and Dinaciclib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01515176: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01515176 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01515176, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and the best dose of ofatumumab and dinaciclib and to see how well they work in treating patients with relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, or B-cell prolymphocytic leukemia. Monoclonal antibodies, such as ofatumumab, can find cancer cells and help kill them. Dinaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ofatumumab together with dinaciclib may kill more cancer cells.
Primary Outcome
Graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0. Assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization.
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Pharmacological Study
- DRUG Dinaciclib
- BIOLOGICAL Ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-01 |
| Est. Completion | 2016-07-19 |
| Phase | Phase 1 |
What the finished NCT01515176 record still lists
NCT01515176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01515176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01515176 about?
NCT01515176 is a clinical study titled "Ofatumumab and Dinaciclib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia". This phase I/II trial studies the side effects and the best dose of ofatumumab and dinaciclib and to see how well they work in treating patients with relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, or B-cell prolymphocytic leukemia. Monoclonal antibodies, such as ofa...
What is the current status of trial NCT01515176?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-01. Estimated completion is 2016-07-19.
What interventions are being tested in trial NCT01515176?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Dinaciclib (DRUG), Ofatumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01515176?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01515176's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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