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NCT01680965 · ClinicalTrials.gov registry record · Phase 1
Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease
A Phase 1 study of Chronic Graft Versus Host Disease, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 4
- Study locations
NCT01680965: Completed Phase 1 study of Chronic Graft Versus Host Disease, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01680965 is a Phase 1 study of Chronic Graft Versus Host Disease that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 44 participants, below the 115-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (62% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01680965, a Phase 1 study of Chronic Graft Versus Host Disease, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 4
- Study locations
Study Summary
To study the safety and side effects of Ofatumumab in the treatment of chronic graft-versus-host disease (GvHD). This study will also evaluate effectiveness of Ofatumumab when added to standard steroid treatment for chronic graft-versus-host disease
Primary Outcome
Maximum Tolerated Dose was determined by increasing doses, beginning at 300 mg on day 0 and day 14, then increasing to 700 mg on day 0 and day 14 and finally 1000 mg on day 0 and day 14.
Conditions Studied
Interventions
- DRUG Ofatumumab
Study Locations (4)
Arizona
- Mayo Clinic Cancer Center - Phoenix
Florida
- H.Lee Moffitt Cancer Center & Research Institute - Tampa
Minnesota
- University of Minnesota - Minneapolis
Washington
- Fred Hutchinson Cancer Research Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2012-11-14 |
| Est. Completion | 2020-08-30 |
| Phase | Phase 1 |
What the finished NCT01680965 record still lists
NCT01680965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 115-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Chronic Graft Versus Host Disease appearing as the primary indexed condition, and to 1 intervention - of which Ofatumumab is the first listed.
NCT01680965 reports a single indexed study location in Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT01680965 about?
NCT01680965 is a clinical study titled "Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease". To study the safety and side effects of Ofatumumab in the treatment of chronic graft-versus-host disease (GvHD). This study will also evaluate effectiveness of Ofatumumab when added to standard steroid treatment for chronic graft-versus-host disease
What is the current status of trial NCT01680965?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2012-11-14. Estimated completion is 2020-08-30.
What conditions does trial NCT01680965 study?
This clinical trial studies the following conditions: Chronic Graft Versus Host Disease.
What interventions are being tested in trial NCT01680965?
The interventions under investigation include: Ofatumumab (DRUG).
Who is sponsoring clinical trial NCT01680965?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01680965 being conducted?
This trial has 4 study locations across Arizona, Florida, Minnesota, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Graft Versus Host Disease
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 NCT01680965's enrollment target sits among peer trials
44 15th of 30 higher than 16 of 30 other Chronic Graft Versus Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Graft Versus Host Disease 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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