NCT05604417

Zandelisib + Tazemetostat in R/R Follicular Lymphoma

A Phase 1 Study With a Phase 2 Expansion Cohort of Zandelisib and Tazemetostat in Relapsed or Refractory Follicular Lymphoma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jacob Soumerai, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is being done to estimate the safety and efficacy of zandelisib and tazemetostat in people with relapsed or refractory follicular lymphoma (FL) This research study involves Zandelisib in combination with Tazemetostat. MEI Pharma, Inc, a biotechnology company, is supporting this research study by providing funding for the research study, including the study drug zandelisib.

Detailed description

This is a phase 1 study of Zandelisib and Tazemetostat with a phase 2 expansion two-arm component in patients with relapsed or refractory follicular lymphoma (FL) grade 1-3A. \- This research study involves Zandelisib in combination with Tazemetostat. This is the first time the drug combination of Zandelisib and Tazemetostat will be given to humans. * The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits * Participants will receive study treatment as long as treatment is tolerated and the disease does not worsen. * The maximum length of time on the study drug combination is 14 months. Participants will followed for up to 2 years. * It is expected that about 34 people will take part in this research study. The U.S. Food and Drug Administration (FDA) has not approved zandelisib as a treatment for any disease. The U.S. FDA has approved tazemetostat as a treatment for relapsed or refractory follicular lymphoma as a single therapy. This is the first time this drug combination will be given to humans. This is a Phase I/II clinical trial. Participants will be asked to participate in either the Phase I part or Phase II part of this clinical trial. * A Phase I clinical trial tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. * A Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

Conditions

• Relapsed Follicular Lymphoma
• Refractory Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	TAZEMETOSTAT	Dosage and treatment timings per protocol
DRUG	Zandelisib	Dosage and treatment timings per protocol

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-01
• Completion: 2026-12-01
• First posted: 2022-11-03
• Last updated: 2023-07-07

Regulatory

• FDA-regulated drug study