PK Study on Ready-to-Use Injection (VSLI-RTU) 1 Vial & 3 Vial Formulation Marqibo® in Hematological Malignant Patients

PHASE1UnknownINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

August 15, 2020

Primary Completion Date

August 15, 2020

Study Completion Date

October 15, 2020

Conditions
Hematologic Diseases
Interventions
DRUG

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.

COMBINATION_PRODUCT

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)

COMBINATION_PRODUCT

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)

Sponsors
All Listed Sponsors
collaborator

Axis Clinicals Limited

INDUSTRY

lead

Acrotech Biopharma Inc.

INDUSTRY

NCT04243434 - PK Study on Ready-to-Use Injection (VSLI-RTU) 1 Vial & 3 Vial Formulation Marqibo® in Hematological Malignant Patients | Biotech Hunter | Biotech Hunter