CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Ibrutinib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02927964
NCT02927964Phase 2Completed

Intratumoral Injection of SD-101, an Immunostimulatory CpG, in Combination With Ibrutinib and Local Radiation in Relapsed or Refractory Low-Grade Follicular Lymphoma

Robert Lowsky·interventional·Posted Oct 7, 2016·Updated Oct 16, 2024

In Brief

A Phase 2 clinical trial evaluating Ibrutinib, Radiation Therapy, and 1 other intervention for Grade 1 Follicular Lymphoma and 6 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 7, 2016
Enrollment StartNov 7, 2016
Primary CompletionMay 18, 2023
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 9.7 years ago

Interventions

Ibrutinibdrug

Given PO

Radiation Therapyradiation

Undergo radiation therapy

TLR9 Agonist SD-101drug

Given IT