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NCT01479842 · ClinicalTrials.gov registry record · Phase 1
Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma
A Phase 1 study of Waldenstrom Macroglobulinemia and Recurrent Mantle Cell Lymphoma, sponsored by Kami Maddocks, MD.
- Active
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT01479842 is a Phase 1 study of Waldenstrom Macroglobulinemia and Recurrent Mantle Cell Lymphoma that is active but no longer recruiting, run by Kami Maddocks, MD. The registered enrollment target is 48 participants, below the 472-participant average among 34 other Waldenstrom Macroglobulinemia trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01479842, a Phase 1 study of Waldenstrom Macroglobulinemia and Recurrent Mantle Cell Lymphoma, is active but no longer recruiting, sponsored by Kami Maddocks, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of BTK inhibitor PCI-32765 when given together with rituximab and bendamustine hydrochloride in treating patients with recurrent non-Hodgkin lymphoma (NHL). BTK inhibitor PCI-32765 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving BTK inhibitor PCI-32765 together with rituximab and bendamustine hydrochloride may kill more cancer cells.
Conditions Studied
Interventions
- BIOLOGICAL rituximab
- OTHER pharmacological study
- DRUG BTK inhibitor PCI-32765
- DRUG bendamustine hydrochloride
- OTHER pharmacogenomic studies
Study Locations (1)
Ohio
- Ohio State University Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-03-26 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01479842
The ClinicalTrials.gov registry entry for NCT01479842 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 472-participant average among 34 other Waldenstrom Macroglobulinemia trials with a reported enrollment target (90% lower). The listed sponsor is Kami Maddocks, MD, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Waldenstrom Macroglobulinemia appearing as the primary indexed condition, and to 5 interventions - of which rituximab is the first listed.
NCT01479842 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT01479842 about?
NCT01479842 is a clinical study titled "Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma". This phase I trial studies the side effects and best dose of BTK inhibitor PCI-32765 when given together with rituximab and bendamustine hydrochloride in treating patients with recurrent non-Hodgkin lymphoma (NHL). BTK inhibitor PCI-32765 may stop the growth of cancer cells by blocking some of the e...
What is the current status of trial NCT01479842?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2014-03-26. Estimated completion is 2026-09-01.
What conditions does trial NCT01479842 study?
This clinical trial studies the following conditions: Waldenstrom Macroglobulinemia, Recurrent Mantle Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Marginal Zone Lymphoma.
What interventions are being tested in trial NCT01479842?
The interventions under investigation include: rituximab (BIOLOGICAL), pharmacological study (OTHER), BTK inhibitor PCI-32765 (DRUG), bendamustine hydrochloride (DRUG), pharmacogenomic studies (OTHER).
Who is sponsoring clinical trial NCT01479842?
This trial is sponsored by Kami Maddocks, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01479842 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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