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NCT01589302 · ClinicalTrials.gov registry record · Phase 2
PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia
A Phase 2 study of Recurrent Small Lymphocytic Lymphoma and Prolymphocytic Leukemia, sponsored by Kami Maddocks, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
- 1
- Study location
NCT01589302 is a Phase 2 study of Recurrent Small Lymphocytic Lymphoma and Prolymphocytic Leukemia that is active but no longer recruiting, run by Kami Maddocks, MD. The registered enrollment target is 154 participants, above the 49-participant average among 14 other Recurrent Small Lymphocytic Lymphoma trials with a reported enrollment target (214% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01589302, a Phase 2 study of Recurrent Small Lymphocytic Lymphoma and Prolymphocytic Leukemia, is active but no longer recruiting, sponsored by Kami Maddocks, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase II, single institution open-label, non-randomized monotherapy study to evaluate the clinical efficacy and durable disease control of PCI-32765 administered to patients with relapsed/refractory CLL/SLL/PLL of all risk categories with patients having deletion 17p13 independently evaluated.
Conditions Studied
Interventions
- DRUG ibrutinib
- OTHER Correlative laboratory samples
- OTHER quality of life assessment
Study Locations (1)
Ohio
- Ohio State University Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2012-05-21 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01589302
The ClinicalTrials.gov registry entry for NCT01589302 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 49-participant average among 14 other Recurrent Small Lymphocytic Lymphoma trials with a reported enrollment target (214% higher). The listed sponsor is Kami Maddocks, MD, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Recurrent Small Lymphocytic Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which ibrutinib is the first listed.
NCT01589302 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT01589302 about?
NCT01589302 is a clinical study titled "PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia". This is a Phase II, single institution open-label, non-randomized monotherapy study to evaluate the clinical efficacy and durable disease control of PCI-32765 administered to patients with relapsed/refractory CLL/SLL/PLL of all risk categories with patients having deletion 17p13 independently evalua...
What is the current status of trial NCT01589302?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2012-05-21. Estimated completion is 2025-12-31.
What conditions does trial NCT01589302 study?
This clinical trial studies the following conditions: Recurrent Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, Refractory/Relapsed Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT01589302?
The interventions under investigation include: ibrutinib (DRUG), Correlative laboratory samples (OTHER), quality of life assessment (OTHER).
Who is sponsoring clinical trial NCT01589302?
This trial is sponsored by Kami Maddocks, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01589302 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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