CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
High Dose Methylprednisolone (HDMP) +2 moredrug
Likely dose
High Dose Methylprednisolone (HDMP) 1000 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/NCT01497496
NCT01497496Phase 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 Relapsed or Refractory CLL/SLL The HiLOG Trial

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Dec 22, 2011·Updated Apr 27, 2021

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 29 participants across 1 site.

Detailed Summary

The main purpose of this study is to see if the combination of ofatumumab with high dose methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can help people with relapsed or refractory CLL/SLL get rid of their CLL/SLL 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 StartJan 26, 2012
Primary CompletionSep 25, 2019
Study CompletionMar 20, 2020
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 14.5 years ago

Interventions

High Dose Methylprednisolone (HDMP)drug

1000 mg/m\^2 on Cycle 1: Day 1, 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15

Ofatumumabdrug

Ofatumumab infusion will be administered immediately after HDMP. 300 mg on Cycle 1 Day 1. 2000 mg on Cycle 1: Day 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15; Cycle 6: Day 1; Cycle 8: Day 1; Cycle 10: Day 1: Cycle 12: Day 1

Lenalidomidedrug

The lenalidomide treatment will start with cycle 4. 5-10 mg pd Days 1-28 as per Creatinine Clearance (CrCl)