A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 22, 2021

Primary Completion Date

July 5, 2023

Study Completion Date

July 5, 2023

Conditions
Relapsed Hematologic MalignancyRefractory Hematologic Malignancy
Interventions
DRUG

Tazemetostat

Orally, twice daily in continuous 28-day cycles.

DRUG

Tafasitamab

Intravenously, 12 mg/kg, once daily on Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle. Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle. Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle.

DRUG

Lenalidomide

Orally, 10 mg or 20 mg based on kidney function, once daily from Days 1 to 21 of continuous 28-day cycles for up to 12 cycles.

DRUG

Acalabrutinib

Orally, 100 mg, twice daily.

DRUG

Daratumumab (Intravenously)

Intravenously, 16 mg/kg actual body weight, once daily on Cycles 1 and 2: Days 1, 8, 15 and 22 of the 28-day cycle. Cycles 3 through 6: Days 1 and 15 each 28-day cycle. Cycle 7 and beyond: Day 1 of each 28-day cycle.

DRUG

Mosunetuzumab

Subcutaneously, step-up doses on Cycle 1 Days 1 (5 mg), 8 (45 mg) and 15 (45 mg) and then 45 mg from Cycle 2 through 12 on Day 1 of the 28-day cycle.

DRUG

Daratumumab (Subcutaneously)

Subcutaneously, 1800 mg, once daily on Cycles 1 and 2: Days 1, 8, 15 and 22 of the 28-day cycle. Cycles 3 through 6: Days 1 and 15 each 28-day cycle. Cycle 7 and beyond: Day 1 of each 28-day cycle.

DRUG

Hyaluronidase-Fihj

Subcutaneously, 30,000 units, once daily on Cycles 1 and 2: Days 1, 8, 15 and 22 of the 28-day cycle. Cycles 3 through 6: Days 1 and 15 each 28-day cycle. Cycle 7 and beyond: Day 1 of each 28-day cycle.

DRUG

Pomalidomide

Orally, 4 mg, once daily on Days 1 to 21 of continuous 28-day cycles.

DRUG

Dexamethasone 20mg

Orally, 20 mg or 40 mg, once daily on Days 1, 8, 15, and 22 of continuous 28-day cycles.

Trial Locations (3)

65613

Central Care Cancer Center, Bolivar

92024

California Cancer Associates For Research And Excellence, cCARE, Santa Fe

08816

Astera Cancer Center, East Brunswick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Epizyme, Inc.

INDUSTRY