NCT03919175

Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma

A Phase 2 Study of Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to assess Umbralisib and Rituximab as a first line therapy for Follicular Lymphoma or Marginal Zone Lymphoma.

Detailed description

This research study is a Phase II clinical trial. 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. The U.S. Food and Drug Administration (FDA) has not approved Umbralisib as a treatment for any disease. The FDA has approved Rituximab as a treatment option for this disease. Umbralisib is an investigational drug which blocks a protein called PI3K. PI3K is a protein that plays a role in the way cells grow. In this type of cancer, PI3K is increased and more active than usual. This helps the cancer cells to grow and survive. Early clinical trials have shown that Umbralisib can kill cancer cells in some patients and cause their tumors to shrink.

Conditions

• Lymphoma
• Follicular Lymphoma
• Follicular Lymphoma, Grade 1
• Follicular Lymphoma Grade 2
• Follicular Lymphoma Grade IIIa
• Marginal Zone Lymphoma
• Marginal Zone B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Umbralisib	Umbralisib is an investigational drug which blocks a protein called PI3K. PI3K is a protein that plays a role in the way cells grow. In this type of cancer, PI3K is increased and more active than usual. This helps the cancer cells to grow and survive.
DRUG	Rituximab	Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells

Timeline

• Start date: 2019-09-01
• Primary completion: 2024-05-05
• Completion: 2024-05-05
• First posted: 2019-04-18
• Last updated: 2026-02-27
• Results posted: 2026-02-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study