CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Agatolimod Sodium +6 moredrug
Likely dose
Rituximab given IV (specific dose not stated); Y-90 Zevalin given IV; Agatolimod Sodium (CpG 7909) given IVAI-extracted
Key inclusion· 7
  • Biopsy-proven relapsed, refractory, or residual CD20+ non-Hodgkin lymphomas
  • Histologic types: small lymphocytic lymphoma, lymphoplasmacytoid, follicular (grades 1-3), extranodal marginal zone, nodal marginal zone, diffuse large cell, or transformed lymphoma
  • ≤25% bone marrow involvement by lymphoma on bilateral bone marrow aspirate and biopsy
  • Bi-dimensionally measurable disease with ≥1 lesion ≥2 cm single diameter
Key exclusion· 10
  • Prior myeloablative therapies with autologous or allogeneic bone marrow/stem cell transplantation
  • Prior radioimmunotherapy (Y-90 Zevalin, I-131 anti-B1, Lym-1)
  • CNS lymphoma
  • Myelodysplastic syndrome or marrow chromosomal changes suggesting myelodysplasia

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

Search/NCT00438880
NCT00438880Phase 2Completed

A Phase I/II Trial of CpG 7909, Rituximab Immunotherapy, and Y-90 Zevalin Radioimmunotherapy for Patients With Previously Treated CD20+ Non-Hodgkin Lymphoma

Mayo Clinic·interventional·Posted Feb 22, 2007·Updated Feb 4, 2016

In Brief

A Phase 2 clinical trial evaluating Agatolimod Sodium, Indium In-111 Ibritumomab Tiuxetan, and 5 other interventions for Adult Non-Hodgkin Lymphoma and 11 related conditions. Completed, enrolled 38 participants across 2 sites.

Detailed Summary

RATIONALE: Biological therapies, such as agatolimod sodium, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving agatolimod sodium together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of agatolimod sodium when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well it works in treating patients with recurrent or refractory non-Hodgkin lymphoma.

Study Details

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2007
Enrollment StartOct 1, 2004
Primary CompletionOct 1, 2010
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 19.4 years ago

Interventions

Agatolimod Sodiumdrug

Given IV

Indium In-111 Ibritumomab Tiuxetanradiation

Given IV

Laboratory Biomarker Analysisother

Correlative study

Radionuclide Imagingprocedure

Undergo imaging scans

Rituximabbiological

Given IV

Single Photon Emission Computed Tomographyprocedure

Undergo imaging scans

Yttrium Y-90 Ibritumomab Tiuxetanradiation

Given IV