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Epigenetic Modifier

PHASE 1: ZANDELISIB + TAZEMETOSTAT for Follicular Lymphoma

Phase 1 & 2

Waitlist Available

Led By Jacob D. Soumerai, MD

Research Sponsored by Jacob Soumerai, MD

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 4 years

Awards & highlights

Study Summary

This trial aims to assess the safety and effectiveness of Zandelisib and Tazemetostat to treat relapsed or refractory Follicular Lymphoma.

Eligible Conditions

Follicular Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Complete Response Rate Phase II

Dose Limiting Toxicities Phase I

Secondary outcome measures

Duration of Response

Median Progression-Free Survival

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: PHASE 1: ZANDELISIB + TAZEMETOSTATExperimental Treatment2 Interventions

Phase 1 study (3+3 design), followed by a phase 2 expansion component For phase 1 portion, which follows the same dosing schedule as Arm A, there will not be any randomization. Zandelisib, oral, daily on predetermined days each cycle for a total of 14 cycles Tazemetostat oral, twice daily on predetermined days (Cycles 1) and predetermined days (Cycles 2-14) for a total of 14 cycles. There will be 2 dose levels of tazemetostat.

Group II: Arm B: Zandelisib and TazemetostatExperimental Treatment2 Interventions

Participants randomized into Arm B of the phase 2 component will receive Zandelisib oral, daily on predetermined days (Cycles 1-2) and predetermined days of cycle 3 and onwards up to 14 cycles. Tazemetostat, oral, twice daily on predetermined days of each cycle. This will begin on cycle 3 and will continue for up to 12 cycles.

Group III: Arm A: COMBINATION ZANDELISIB + TAZEMETOSTATExperimental Treatment2 Interventions

Participants randomized into Arm A of the phase 2 component will receive Zandelisib, oral, daily on predetermined days each cycle for a total of 14 cycles Tazemetostat oral, twice daily on predetermined days (Cycles 1) and predetermined days (Cycles 2-14) for a total of 14 cycles

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Who is running the clinical trial?

Jacob Soumerai, MDLead Sponsor

1 Previous Clinical Trials

25 Total Patients Enrolled

MEI Pharma, Inc.Industry Sponsor

13 Previous Clinical Trials

878 Total Patients Enrolled

Jacob D. Soumerai, MDPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

41 Total Patients Enrolled

Frequently Asked Questions

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

What aims are being pursued with this medical research?

"This long-term trial aims to measure Dose Limiting Toxicities Phase I over a 4 year period, with secondary objectives being Overall Survival, Number of Participants With Treatment Related Adverse Events (as assessed by CTCAE v5.0) and Duration of Response (measured from first meeting criteria for CR or PR until disease progression)."

Answered by AI

Are there still vacancies in this experiment for participants?

"At this moment in time, clinicaltrials.gov has recorded that no patients are being accepted for inclusion into the trial which was initially posted on 1/1/2023 and most recently updated on 10/28/2020. Despite this, there exist a plethora of other medical studies with 1719 recruiting participants currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Zandelisib + Tazemetostat in R/R Follicular Lymphoma

Jacob Soumerai, MD 2023. "Zandelisib + Tazemetostat in R/R Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05604417.