Rituximab + High-Dose Methylprednisolone Debulking Prior to Venetoclax for CLL & SLL Patients

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

September 2, 2021

Primary Completion Date

July 22, 2025

Study Completion Date

July 22, 2026

Conditions
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Interventions
DRUG

HDMP + rituximab as a means of debulking prior to initiating venetoclax.

"* Patients will receive HDMP + Rituximab for 1 cycle, followed by reassessment of Tumor Burden,~* If Tumor Burden classification is low after HDMP + Rituximab (lymph nodes \< 5cm in diameter AND absolute lymphocyte count \< 25k/uL), patients will initiate venetoclax dose ramp-up, with ramp-up schedule according to venetoclax package insert.~* Patients who still have a disease burden (lymphadenopathy \> 5 cm or ALC \> 25k/iL) that meets criteria for medium or high risk of TLS after 1 cycle of HDMP + Rituximab are given the option to repeat a 2nd cycle of HDMP + Rituximab prior to venetoclax dose ramp-up."

Trial Locations (1)

92093

UCSD Moores Cancer Center, La Jolla

All Listed Sponsors
lead

University of California, San Diego

OTHER