56
Participants
Start Date
August 15, 2020
Primary Completion Date
August 15, 2020
Study Completion Date
October 15, 2020
Vincristine Sulfate Liposome
Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment cohorts (Cohorts A or B) to receive either the first cycle of treatment with the VSLI-RTU formulation or the Marqibo formulation and crossover to the other formulation for the second cycle.
CHOP
CHOP to be administered on Day 1 on Cycle 1 \& 2 ( 21-day Cycle) \& prednisone administration on Days 2 to 5 on Cycle 1 \& 2 ( 21-day Cycle)
R-CHOP
R-CHOP to be administered on Day 1 on Cycle 1 \& 2 ( 21-day Cycle) \& prednisone administration on Days 2 to 5 on Cycle 1 \& 2 ( 21-day Cycle)
Lead Sponsor
Collaborators (1)
Axis Clinicals Limited
INDUSTRY
Acrotech Biopharma Inc.
INDUSTRY