CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
High Dose Methylprednisolone (HDMP) +2 moredrug
Likely dose
Not stated in 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/NCT01496976
NCT01496976Phase 2Completed
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Phase II Study of Ofatumumab in Combination With High Dose Methylprednisolone Followed by Ofatumumab and Lenalidomide Consolidative Therapy for the Treatment of Untreated CLL/SLL The HiLOG Trial

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Dec 22, 2011·Updated Dec 19, 2025

In Brief

A Phase 2 clinical trial evaluating High Dose Methylprednisolone (HDMP), Ofatumumab, and 1 other intervention for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Completed, enrolled 45 participants across 1 site.

Detailed Summary

The main purpose of this study is to see if ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can help people with Chronic Lymphocytic Leukemia (CLL) get rid of their CLL for a long period of time. Researchers also want to find out if the combination of ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide is safe and tolerable.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
CountriesUnited States
CollaboratorsNovartis, Celgene Corporation

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 22, 2011
Enrollment StartMar 30, 2012
Primary CompletionOct 6, 2021
Study CompletionSep 11, 2024
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 14.5 years ago

Interventions

High Dose Methylprednisolone (HDMP)drug

HDMP will be administered at 1 gm/m\^2 IV over 90 minutes daily with ofatumumab infusions 1-8.

Ofatumumabdrug

Ofatumumab infusion will be administered immediately after HDMP.

Lenalidomidedrug

The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.