NCT01497496 - Ofatumumab/Methylprednisolone and Ofatumumab/Lenalidomide for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 26, 2012

Primary Completion Date

September 25, 2019

Study Completion Date

March 20, 2020

Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Interventions

DRUG

High Dose Methylprednisolone (HDMP)

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

DRUG

Ofatumumab

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

DRUG

Lenalidomide

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

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa