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Immunotherapy

Arm 4-Tazemetostat plus CD38 mAbPD (daratumumab/pomalidomide/dexamethasone) for Hematologic Malignancies (ARIA Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Epizyme, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

ARIA Trial Summary

This trial looks at the safety of using the drug tazemetostat with other treatments for blood cancer. Tazemetostat has been found to be a safe and effective drug for patients with relapsed refractory follicular lymphoma. Giving tazemetostat in combination with other treatments may work better in treating patients with blood cancer and may improve disease response and durability of response.

Eligible Conditions

Hematologic Malignancies
Hematologic Malignancy

ARIA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1b: Recommended Phase 2 Dose (RP2D) of tazemetostat in combination with each partner drug

Phase 2: Objective Response Rate (ORR)

Secondary outcome measures

Percentage of participants with Treatment Emergent Adverse Event (TEAEs)

Percentage of participants with clinically significant changes in laboratory parameters

Phase 2: Disease control rate (DCR)

+5 more

ARIA Trial Design

5Treatment groups

Active Control

Group I: Arm 4-Tazemetostat plus CD38 mAbPD (daratumumab/pomalidomide/dexamethasone)Active Control5 Interventions

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.

Group II: Arm 1-Tazemetostat plus tafasitamab-cxix (CD19 Ab)/lenalidomideActive Control3 Interventions

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.

Group III: Arm 2-Tazemetostat plus lenalidomideActive Control2 Interventions

Participants with R/R DLBCL will receive tazemetostat and lenalidomide for approximately 1 year. After approximately 1 year, participants will receive tazemetostat alone.

Group IV: Arm 3- Tazemetostat plus BTKi (acalabrutinib)Active Control3 Interventions

Participants with R/R mantle cell lymphomawill (MCL) will receive tazemetostat and acalabrutinib for the entire study.

Group V: Arm 5- Tazemetostat plus CD20/CD3 BsAb (mosunetuzumab)Active Control2 Interventions

Participants with R/R follicular lymphoma will receive tazemetostat and mosunetuzumab for approximately 1 year. After approximately 1 year, participants will receive tazemetostat alone.

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Who is running the clinical trial?

Epizyme, Inc.Lead Sponsor

33 Previous Clinical Trials

2,854 Total Patients Enrolled

Ipsen Medical DirectorStudy DirectorIpsen

257 Previous Clinical Trials

55,145 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients being recruited for this clinical trial at present?

"This clinical trial is looking for patients. According to the information on clinicaltrials.gov, the trial was first posted on December 22, 2021 and was last updated on October 20, 2022."

Answered by AI

How many people are being asked to participate in this clinical trial?

"Yes, the information available on clinicaltrials.gov verifies that this trial is currently looking for enrollees. This specific trial was first posted on December 22nd, 2021 and was last updated on October 20th, 2022. The study needs a total of 156 patients from 2 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05205252.