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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: Active Phase 2 study of Recurrent Small Lymphocytic Lymphoma and Prolymphocytic Leukemia, sponsored by Kami Maddocks, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We will summarize our findings for this endpoint independently as well within each cohort (del17p vs other cytogenetic groups). We will evaluate the proportion of patients who are progression-free and alive at two years or have gone on to transplant (treatment successes) over the total number of evaluable patients; eligible patients who received at least one dose of therapy are considered evaluable. Assuming that the number of treatment successes as defined above is binomially distributed, we wi
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 |
What the registry record for NCT01589302 still lists
NCT01589302 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 49-participant average among 14 other Recurrent Small Lymphocytic Lymphoma trials with a reported enrollment target (214% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Recurrent Small Lymphocytic Lymphoma
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 NCT01589302's enrollment target sits among peer trials
154 3rd of 14 higher than 12 of 14 other Recurrent Small Lymphocytic Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Small Lymphocytic Lymphoma 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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