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

Summary

This trial will study how safely the tazemetostat works with other therapies in various hematological malignancies. Hematologic malignancies are cancers that most often begin in the bone marrow or lymph nodes where blood precursors are produced.

They are often called blood cancers and fall into three categories: leukemia, lymphoma and myeloma.

Tazemetostat has been found to be a safe and effective drug that works in patients with follicular lymphoma where the disease has come back after treatment (known as relapsed) and when other treatment no longer works (known as refractory).

Combining tazemetostat with other treatments may work better in treating patients with hematological malignancies and may improve disease response and durability of response.

Conditions

• Relapsed Hematologic Malignancy
• Refractory 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.

Sponsors & Collaborators

• Epizyme, Inc.

  lead INDUSTRY

Principal Investigators

• Ipsen Medical Director · Ipsen

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-22

Primary Completion

2023-07-05

Completion

2023-07-05

FDA Drug

Yes

Countries

• United States

Study Locations