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NCT02927964 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Robert Lowsky.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT02927964: Completed Phase 1 study, sponsored by Robert Lowsky.

NCT02927964 is a Phase 1 study that has completed, run by Robert Lowsky. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02927964, a Phase 1 study, has completed, sponsored by Robert Lowsky.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study 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.

Primary Outcome

Dose-limiting toxicity was continuously throughout the trial. Adverse event information was collected at each visit. Safety labs were collected on week 2, 4, 6, 12 and every 12 weeks thereafter until the final study visit.

Interventions

  • RADIATION Radiation Therapy
  • DRUG Ibrutinib
  • DRUG TLR9 Agonist SD-101

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2016-11-07
Est. Completion 2023-05-18
Phase Phase 1
Robert Lowsky

6 total trials

What the finished NCT02927964 record still lists

NCT02927964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 3 interventions - of which Radiation Therapy is the first listed.

NCT02927964 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02927964 about?

NCT02927964 is a clinical study titled "TLR9 Agonist SD-101, Ibrutinib, and Radiation Therapy in Treating Patients With Relapsed or Refractory Grade 1-3A Follicular Lymphoma". 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 ...

What is the current status of trial NCT02927964?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2016-11-07. Estimated completion is 2023-05-18.

What interventions are being tested in trial NCT02927964?

The interventions under investigation include: Radiation Therapy (RADIATION), Ibrutinib (DRUG), TLR9 Agonist SD-101 (DRUG).

Who is sponsoring clinical trial NCT02927964?

This trial is sponsored by Robert Lowsky, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02927964's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02927964, the US trial registry maintained by the National Library of Medicine. NCT02927964 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.