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TLR9 Agonist SD-101, Ibrutinib, and Radiation Therapy in Treating Patients With Relapsed or Refractory Grade 1-3A Follicular Lymphoma

NCT02927964 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-10-16

Study results available
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Summary

This phase Ib/II trial studies the side effects and best dose of toll-like receptor 9 (TLR9) agonist SD-101 when given together with ibrutinib and radiation therapy and to see how well they work in treating patients with Low Grade Follicular Lymphoma, Marginal Zone Lymphoma, or Mantle Cell Lymphoma that has come back after a period of improvement or no longer responds to treatment. Immunostimulants such as TLR9 agonist SD-101 may increase the ability of the immune system to fight infection and disease. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving TLR9 agonist SD-101 with ibrutinib and radiation therapy may induce an immune response and prolong anti-tumor response.

Conditions

Interventions

DRUG

Ibrutinib

Given PO

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

TLR9 Agonist SD-101

Given IT

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Rising Tide Foundation

    collaborator OTHER

  • Robert Lowsky

    lead OTHER

Principal Investigators

  • Ronald Levy · Stanford University

  • Michael Khodadoust · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-07
Primary Completion
2023-05-18
Completion
2023-05-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02927964 on ClinicalTrials.gov