Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter's Syndrome

PHASE1CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

December 20, 2017

Primary Completion Date

May 2, 2022

Study Completion Date

May 2, 2022

Conditions
Richter's SyndromeCLL
Interventions
DRUG

Obinutuzumab

obinutuzumab 1000 mg x 8 doses (first dose split on Cycle 1 days 1 100mg and 2 900mg; then day 8 and 15 of cycle 1; then day 1 of cycles 2-6, each cycle being 28 days long)

DRUG

lenalidomide

lenalidomide PO daily. The starting dose of lenalidomide is 5 mg PO daily. Starting on C2D1, the dose increases every 2 weeks in 5 mg increments to a maximum of 25 mg PO daily. Patients will continue lenalidomide until disease progression, unacceptable toxicity, or subsequent therapy.

DRUG

HDMP

methylprednisolone 1000 mg/m2 (ie HDMP) on days 1-5 of cycles 1-4

Trial Locations (1)

92093

University of California, San Diego, La Jolla

All Listed Sponsors
lead

University of California, San Diego

OTHER

NCT03113695 - Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter's Syndrome | Biotech Hunter | Biotech Hunter