CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
CPG 7909drug
Likely dose
CPG 7909 6 mg intratumoral injection immediately before 2 Gy radiotherapy, repeated at 24 hours (second 2 Gy), then weekly for 8 additional weeks (total 10 injections)AI-extracted
Key inclusion· 6
  • Biopsy-confirmed low-grade B-cell lymphoma (any stage) with prior treatment failure, or mycosis fungoides stage IB-IVA with prior treatment failure or intolerance.
  • At least one tumor site accessible for percutaneous intratumoral injection.
  • Measurable disease outside the injection and biopsy sites.
  • Tumor biopsy specimens available (prior or new) for immunological studies.
Key exclusion· 7
  • Pre-existing autoimmune or antibody-mediated disease (SLE, rheumatoid arthritis, multiple sclerosis, Sjögren's, autoimmune thrombocytopenia), excluding controlled thyroid disease or autoantibodies without clinical disease.
  • Known HIV, hepatitis B, or hepatitis C (active, prior treatment, or both).
  • Active infection or fever ≥38.5°C within 3 days prior to first treatment.
  • CNS metastases.

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

Search/NCT00185965
NCT00185965Phase 2Completed

Le23 CPG: A Phase 1-2 Study of Intratumoral Injection of CPG 7909, A TLR 9 Agonist, Combined With Local Radiation in Recurrent Low-Grade Lymphomas

Ronald Levy·interventional·Posted Sep 16, 2005·Updated Aug 1, 2014

In Brief

A Phase 2 clinical trial evaluating CPG 7909 for Non-Hodgkin Lymphoma and Mycosis Fungoides. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Brief summary TBD

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJul 1, 2004
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 20.8 years ago

Interventions

CPG 7909drug

6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).