CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Ofatumumabdrug
Likely dose
Ofatumumab 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01680965
NCT01680965Phase 2Completed
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Ofatumumab in Combination With Glucocorticoids for Primary Therapy of Chronic Graft Versus Host Disease

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Sep 7, 2012·Updated Oct 6, 2022

In Brief

A Phase 2 clinical trial evaluating Ofatumumab for Chronic Graft Versus Host Disease. Completed, enrolled 44 participants across 4 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Graft Versus Host Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 7, 2012
Enrollment StartNov 14, 2012
Primary CompletionAug 1, 2020
Study CompletionAug 30, 2020
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 13.8 years ago

Interventions

Ofatumumabdrug

Phase I: test an escalating dose of ofatumumab at cohorts of 300 mg, 700 mg, and 1000 mg given on day 0 and 14 of study. Phase II: Ofatumumab MTD on day 0 and 14; patients will be followed for total of 24 months (months 1, 3, 6, 12 after therapy, then at 18 and 24 months following therapy)