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

Conditions

• Refractory Hematologic Malignancy
• Relapsed Hematologic Malignancy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tazemetostat — DRUG
  Orally, twice daily in continuous 28-day cycles.
• Tafasitamab — DRUG
  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.
• Lenalidomide — DRUG
  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.
• Acalabrutinib — DRUG
  Orally, 100 mg, twice daily.
• Daratumumab (Intravenously) — DRUG
  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.
• Mosunetuzumab — DRUG
  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.
• Daratumumab (Subcutaneously) — DRUG
  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.
• Hyaluronidase-Fihj — DRUG
  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.
• Pomalidomide — DRUG
  Orally, 4 mg, once daily on Days 1 to 21 of continuous 28-day cycles.
• Dexamethasone 20mg — DRUG
  Orally, 20 mg or 40 mg, once daily on Days 1, 8, 15, and 22 of continuous 28-day cycles.

Study Details

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.

Key Dates

Start date

Dec 22, 2021

Status verified

Aug 2023

Primary completion

Jul 5, 2023

Completion

Jul 5, 2023

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1-Tazemetostat plus tafasitamab-cxix (CD19 Ab)/lenalidomide
  Participants with R/R, diffuse large B-cell lymphoma (DLBCL) will receive tazemetostat, tafasitamab, and lenalidomide for approximately 1 year. After approximately 1 year, participants will receive tazemetostat and tafasitamab.
• Active Comparator: Arm 2-Tazemetostat plus lenalidomide
  Participants with R/R DLBCL will receive tazemetostat and lenalidomide for approximately 1 year. After approximately 1 year, participants will receive tazemetostat alone.
• Active Comparator: Arm 3- Tazemetostat plus BTKi (acalabrutinib)
  Participants with R/R mantle cell lymphomawill (MCL) will receive tazemetostat and acalabrutinib for the entire study.
• Active Comparator: Arm 4-Tazemetostat plus CD38 mAbPD (daratumumab/pomalidomide/dexamethasone)
  Participants with R/R multiple myelomawill (MM) will receive tazemetostat, daratumumab, pomalidomide, and dexamethasone for the entire study. Daratumumab may be given intravenously or subcutaneously during this study.
• Active Comparator: Arm 5- Tazemetostat plus CD20/CD3 BsAb (mosunetuzumab)
  Participants with R/R follicular lymphoma will receive tazemetostat and mosunetuzumab for approximately 1 year. After approximately 1 year, participants will receive tazemetostat alone.

Primary Outcome Measure

Phase 1b: Recommended Phase 2 Dose (RP2D) of tazemetostat in combination with each partner drug [ Time Frame: Evaluated for DLTs during the first 28-day cycle. The RP2D for Phase 2 for each arm will be selected at the end of that arm's experience in Phase 1b ]

Locations (3)

Find similar trials in Santa Fe, CA

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